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Evaluation and comparison of anxiety levels after using Guided Imagery technique for relaxation and modified Guided Imagery-Hypnotherapy technique in 6 to 14 year-old children undergoing local anesthesia administration

[version 1; peer review: 2 approved with reservations]
PUBLISHED 18 Aug 2023
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Anxiety has been defined as a “vague, unpleasant feeling accompanied by a premonition that something undesirable is about to happen”. Dental anxiety is driven by a strong negative or unpleasant emotion towards a dental office or dental procedures. Children with a high level of dental anxiety are more resistant to treatment, and due to this avoidance in dental care can lead to needing more dental treatments. The quality of a treatment being carried out, as well as what materials that are to be used, is directly influenced by a child’s level of cooperation and ability to follow instructions. Behaviour management techniques play a major role during all paediatric treatment procedures, and it is the clinician who is responsible to properly and safely guide the child’s behaviour. Guided Imagery is a visual and sensory-based complementary and alternative medicine (CAM) technique. In hypnotherapy which is a type of mind-body intervention; increased suggestibility is used in the treatment of a medical or psychological disease or condition. Therefore, there is a need of a newer modality based on guided imagery and hypnotherapy to be used in as a whole or in tandem with other conventional behaviour management techniques. The aim of this study is to evaluate and compare anxiety levels after using Guided Imagery for relaxation and modified Guided Imagery-Hypnotherapy techniques in 6-14 year-old children undergoing local anesthesia administration.

Keywords

Guided Imagery, Hypnotherapy, Anxiety, Local Anesthesia, Children

Introduction

Anxiety has been defined as a “vague, unpleasant feeling accompanied by a premonition that something undesirable is about to happen”.1 Although the terms “anxiety” and “fear” are frequently interchanged, anxiety is usually described as a general feeling, whereas fear is described as a reaction to a specific event or object.1 Dental anxiety is a phenomenon comprising of various physical, mental as well as social aspects. In the terms of dental fear and anxiety (DFA), dental anxiety is characterized as significant negative or unpleasant feeling about a dental office and dental procedures, whereas dental phobia is an irrational form of dental anxiety.2 Dental anxiety is a major contributor to poor oral health. People mainly delay dental treatment because they are afraid of the discomfort.3

Dental injection fear continues to be a critical concern that frequently requires cognitive behavioural psychology counselling and anesthesia in order to complete necessary dental treatment.3 Trypanophobia is an unreasonable fear of medical treatments involving needles (such as injections), whereas belonephobia is an irrational fear of needles and pins, which can cause unusual behaviour and anxiety. Receiving injections is one of the most frequently expressed fears. Since the delivery of local anaesthetic via injection is the main procedure in pain reduction techniques, needle anxiety is of big concern.4 Children who have a high level of dental anxiety are more resistant to treatment and require more time on dentist’s chair. DFA has the potential to have long-term detrimental consequences on individuals due to avoidance of dental care which results in the need for more dental treatments.5

Complementary and Alternative Medicine (CAM) refers to a range of techniques that are commonly used in conjunction with mainstream medicine, rather than as a replacement for it. Integrative medicine refers to the use of conventional medicine in combination with complementary and alternative therapies.

Guided Imagery is one of the complementary and alternative medicine (CAM) practice that involves a visual and sensory orientation. For a specific intention (such as relaxation, health, performance, or emotional release), in guided imagery one can be directed through a visual experience involving all five senses: imagined sight, smell, hearing, touch, and taste.6 These techniques are suitable for pediatric patients because they are more receptive to suggestions as their imaginations are more active than adult patients. Although children as young as age six to early adolescence can respond to hypnosis, these techniques are most effective when employed with children aged 8 to 12 years.7

Hypnosis a natural altered state of consciousness. The hypnotic state is a deeply relaxed condition similar to that which occurs just before falling asleep.8 In dentistry, hypnosis is referred to as ‘hypnodontics’. The human mind can create extremely real responses from imaginary events and if they are imagined vividly and with enough detail, our body experiences a physical reaction even at a simple thought. Suggestibility is defined as an attitude or collection of behaviours that allows a person to respond to a wide range of stimuli.9 Humans are suggestible by nature, and suggestion as per Heap and Aravind is “a communication delivered verbally by the hypnotist that leads the subject’s imagination in such a way as to elicit intended changes in sensations, perceptions, feelings, thoughts, and behaviour”.10 Hypnotherapy is a type of mind-body intervention in which hypnosis is used to create a state of focused attention and increased suggestibility in the treatment of a medical or psychological disorder or concern.11 Hence, hypnotherapy can be used alone or in combination with other behaviour modification strategies.

The stress response is influenced by cortisol levels, a steroid hormone produced by the adrenal glands. An increase in serum cortisol synthesis by the adrenal cortex lead to a consequent rise in salivary cortisol levels. Cortisol is released in reaction to stress, and it interacts with the hormonal and immunological systems in complex ways. It activates the hypothalamus–pituitary axis, causing the hormone ACTH to be secreted, which then acts on the adrenal cortex, resulting in an increase in salivary cortisol levels.12

Hence the focus of this research, according to the available literature, is to evaluate and compare relaxation guided imagery and modified guided imagery-hypnotherapy for assessment of anxiety levels during local anaesthetic administration in 6 to 14 year-old children.

Protocol

The aim of this study is to evaluate and compare anxiety levels after using Guided Imagery for relaxation and modified Guided Imagery-Hypnotherapy techniques in 6–14-year-old children undergoing local anesthesia administration.

Objectives are:

  • 1. To evaluate the levels of anxiety after using Guided Imagery technique for relaxation in 6–14 year-old children undergoing local anesthesia administration.

  • 2. To evaluate the levels of anxiety after using modified Guided Imagery-Hypnotherapy technique in 6–14-year-old children undergoing local anesthesia administration.

  • 3. To compare the effect of anxiety levels after using Guided Imagery for relaxation technique with modified Guided Imagery-Hypnotherapy technique on in 6–14-year-old children undergoing local anesthesia administration.

This randomized clinical trial will be conducted in an isolated setup over a period of two years (June 2022–June 2024). It will be performed within a single visit. Children from six to 14 years old who are healthy, co-operative but anxious and children undergoing dental treatment requiring administration of local anesthesia at the Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research will be included in the study.

Children with past exposure to local anesthesia, known allergy to local anaesthetic agent, psychological abnormalities, children with special health care needs, children suffering from systemic diseases and with parents who are unwilling to participate will be excluded from the study.

Group 1 – Guided Imagery technique for relaxation: (Figure 1)

4aa9dd35-05da-49cd-b915-0eaa42cd2030_figure1.gif

Figure 1. Group 1 – Guided Imagery technique for relaxation.

The Guided Imagery technique for relaxation is designed for children undergoing dental treatment. This approach is the Relaxation-guided imagery method based on Vagnoli, L., Bettini, A., Amore, E. et al.13 By taking deep breaths, the child can focus on their body and gradually release muscle tension from the feet to the head. A mental recreation of sights, sounds, smells, tastes, and feelings as though they were truly happening while instructing to imagine a favourite place, real or imagined, using the same terms for each participant; and after the child remains in the chosen location for a while, contact with the surrounding world is gradually reestablished until the child opens his or her eyes.

Group 2 – Modified Guided Imagery-Hypnotherapy technique: (Figure 2)

4aa9dd35-05da-49cd-b915-0eaa42cd2030_figure2.gif

Figure 2. Group 2 – Modified Guided Imagery-Hypnotherapy technique.

Modified Guided Imagery-Hypnotherapy is a combination of guided imagery, hypnotherapy along with colour psychology and it only requires relatively low levels of hypnosis to help the child calm. Modified guided imagery technique is based on general information on creating positive mental imagery (Stein, 2013),14 as well as the guidelines of the PETTLEP (Physical, Environment, Task, Timing, Learning, Emotion and Perspective) model of imagery (Holmes and Collins, 2001)14 and colour psychology.15 In this, a combination of above concepts will be used. The child will be shown a colour pinwheel while taking a few slow and deep breaths (about five to 10 times).

The child will then be told to close their eyes and imagine themselves becoming peaceful and relaxed, as well as smiling, feeling pleased, and having fun. The dental chair will be utilised as an anchor item, and the child will be encouraged to open their eyes and feel safe around the dental. This procedure will be repeated two to three times until the child is completely relaxed. The child will then be asked to gently open their eyes.

Group 3 – Control group

Intervention of conventional behaviour management techniques like tell-show-do, ask-tell-ask, positive reinforcement, modelling, systemic desensitization and voice control will be done.7

The study is a randomized clinical trial, and this is the version one of the protocol. Sequences by random numbers will be computer-generated. The co-investigator of the department will generate the allocation sequence and will assign participants to interventions. Trial participants, and data analysts will be blinded. Trial participants will not be aware in which group they will be allotted hence they will be blinded. The data analysts will be provided with the data chart without revealing the intervention groups to maintain blinding. Data management by double data entry will be done. Personal information about potential and enrolled participants will be collected and maintained in order to protect confidentiality before, during, and after the trial. All study-related information will be stored securely at the study site.

All participant information will be stored in locked file cabinets in areas with limited access.

All laboratory specimens, reports, data collection, process, and administrative forms will be identified by a coded identification number only to maintain participant confidentiality.

Comparators guided imagery and conventional behaviour management method will be taken into consideration for comparing as all of them are interventions aiding for reducing the anxiety levels.

The sample size of a 45 in total was calculated with reference of study by Oberoi et al (2016)6 using the sample size formula for difference between two means.

Δ=107.92103.93=3.99
n=1.96+0.8424.652+4.462/13.9=10.97

n = 15 patients needed in each group

VFAS score using the Visual Facial Anxiety Scale for scoring anxiety16 and salivary cortisol levels as a biological indicator using salivary cortisol ELISA kit are the primary outcomes to be measured. VFAS score will be noted before and after the intervention. The salivary samples will be collected at the start and end of the intervention for measuring the salivary cortisol levels. The difference between the given two time points will be used to assess the clinical significance of the primary outcomes. Physical resistance, verbal resistance, tension in the muscles, co-operation during local anaesthesia administration are the secondary outcomes to be measured. All the outcomes will be measured before, during and after intervention.

Data analysis and statistical plan

Analytical tests like the Chi square test and student’s t-test will be performed for analysing data collected from the VFAS and salivary cortisol samples. All the statistical analysis will be performed using SPSS software, version 27.0. p<0.05 will be considered as the level of significance. This randomized clinical trial will be conducted at the Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Wardha, India. The allocation of participants will be done using computer generated numbers.

Dissemination

Once completed the study will be published in a PubMed and Scopus indexed journal.

Study status

This trial is yet to be started.

Ethical considerations

Ethical approval for the study was obtained from the Institutional ethics committee of Datta Meghe Institute of Medical Sciences (Deemed to be University) [ref no: DMIMSU (DU)/IEC/2022/756].

The study protocol will be explained to the participating children and their parents. Further, written informed consent for participation will be obtained from the parents.

Trial registration

Trial Registration is done under The Clinical Trials Registry - India (CTRI reference no- REF/2022/06/055009)

Date of Registration: 06/09/2022

https://ctri.nic.in/Clinicaltrials/showallp.php?mid1=70398&EncHid=76235.25564&userName=Effectiveness%20of%20guided%20imagery%20and%20modified%20guided%20imagery%20in%20reduction%20of%20anxiety%20in%20children

Discussion

There are various studies done for using integrative medicine techniques. A study by Oberoi et al. (2016) included 200 children aged 6 to 16 that checked the anxiety states of the child by using the parameters – patient’s heart rate, oxygen saturation, physical and/or verbal resistance during local anesthesia administration. Patients were divided into two groups – hypnotic group and control group. The difference in behaviour between hypnotized and non-hypnotized children was related to the child’s calm frame of mind. Hypnosis could improve patient compliance, reduce resistance during unpleasant operations, and lower heart rates.6

A study analysed the effects of H (hypnosis) and progressive muscle relaxation therapy (PMR) on anxiety, pain in a randomized control experiment. A total of 60 children were divided into three groups between the age group of eight to 12 years. There was a reduction in anxiety levels validated by reduction in blood pressure, heart rate and in reduction in pain validated by lowered need for analgesics, whereas the SPO2 remained constant throughout in the experimental group of hypnosis “H” and progressive muscle relaxation “PMR”. Hypnosis and PMR were effective for anxiety reduction and pain control in pediatric dentistry patients.17

A link between stress and anxiety with salivary cortisol (SC) and salivary alpha-amylase (SAA) levels was evaluated in a study with 20 children in the age group of 5–12 years. Pre- and post-extraction saliva samples were collected and a positive co-relation was seen against a graph plotted for post extraction salivary cortisol and salivary amylase levels. It was indicative of activation of adrenal medulla by the signals from sympathetic system leading to increase in salivary secretions containing high levels of cortisol and alpha amylase in stressful and anxious situations. Saliva can be used as a new non-invasive approach of evaluating anxiety and stress by analysing the levels of stress indicators.12

A randomized clinical study that included 48 subjects in total evaluated nature-based guided imagery (GI), urban-based GI and GI as a process within itself for reduction in state anxiety levels. The process used a set of 20 questions indicating trait anxiety to determine participant appropriateness for the study. The interventions in this research were two GI sessions, one of which was held in a natural setting and the other in an urban setting. Each subject was exposed to both conditions. Anxiety can be effectively treated with GI itself, and at the same time nature-based GI and urban-based GI was useful too. But the most effective GI, was said to be nature-based and hence the study concluded that nature-based GI interventions are effective anxiety management interventions which have the added benefit of being cost-effective and easily accessible.18

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Parakh H and Thosar N. Evaluation and comparison of anxiety levels after using Guided Imagery technique for relaxation and modified Guided Imagery-Hypnotherapy technique in 6 to 14 year-old children undergoing local anesthesia administration [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:1000 (https://doi.org/10.12688/f1000research.133423.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
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PUBLISHED 18 Aug 2023
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Reviewer Report 06 Jun 2024
Vivek Padmanabhan, RAK Medical and Health Sciences University,, Ras Al Khaimah, United Arab Emirates;  RAK College of Dental Sciences, Ras Al Khaimah, United Arab Emirates 
Approved with Reservations
VIEWS 4
Dear authors
I would like to begin by congratulating the authors on their initiative in undertaking this study. I hope my feedback will be helpful for further development.

Initially, the article appears to aim at comparing ... Continue reading
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Padmanabhan V. Reviewer Report For: Evaluation and comparison of anxiety levels after using Guided Imagery technique for relaxation and modified Guided Imagery-Hypnotherapy technique in 6 to 14 year-old children undergoing local anesthesia administration [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:1000 (https://doi.org/10.5256/f1000research.146412.r281227)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Reviewer Report 29 May 2024
Mohamed Jaber, Ajman University, Ajman, United Arab Emirates 
Approved with Reservations
VIEWS 4
  • The protocol outlines clear objectives, inclusion and exclusion criteria, and the methodology for conducting the study.
  • The study design, a randomized clinical trial, is appropriate for evaluating the effectiveness of the interventions.
  • The
... Continue reading
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CITE
HOW TO CITE THIS REPORT
Jaber M. Reviewer Report For: Evaluation and comparison of anxiety levels after using Guided Imagery technique for relaxation and modified Guided Imagery-Hypnotherapy technique in 6 to 14 year-old children undergoing local anesthesia administration [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:1000 (https://doi.org/10.5256/f1000research.146412.r281221)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

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VERSION 1 PUBLISHED 18 Aug 2023
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Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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