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Effects of Imagery Therapy vs Progressive Muscle Relaxation Therapy on Patients With Functional Abdominal Bloating

Primary Purpose

Functional Gastrointestinal Disorders

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Guided Imagery
Progressive Muscle Relaxation
Educational Audiobook
Sponsored by
Universiti Sains Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Gastrointestinal Disorders focused on measuring Guided Imagery, Progressive Muscle Relaxation, Relaxation Techniques, Psychotherapy, Hypnosis, Sports Psychology, Bloating, Gastrointestinal Disease, Distention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants with abdominal bloating as determined using the Malay version Rome III criteria which was validated and translated by past researchers (Lee et al, 2012) and/or patients who were suggested by clinicians.
  • Participants must be 18 years and above, and of either gender.
  • Participants are able to read, write, or understand the Malay language.

Exclusion Criteria:

  • Patients with abdominal bloating due to organic disorder
  • Patients with recent abdominal surgeries (within 3 months) or previous major abdominal surgeries
  • Patients with major neurological and psychological disorders including stroke, schizophrenia, major depression.
  • Patients with medical history which may be the red flag for other FGIDs and organic disorders .
  • Patients who are on psychotropic medications or psychotherapy which may confound outcome of imagery of sham intervention.

Sites / Locations

  • Universiti Sains Malaysia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Guided Imagery (GI)

Progressive Muscle Relaxation (PMR)

Audiobook

Arm Description

A 8 minute audio that focuses on evoking mental images in reducing the abdominal bloating sensation in patients

A 8 minute audio that focuses on contracting certain muscle groups and relaxing it progressively in reducing the abdominal bloating sensation in patients

A 8 minute audio that focuses on providing educational information regarding functional gastrointestinal disorders and related knowledge.

Outcomes

Primary Outcome Measures

Symptoms severity
Measured using the Malay version of Bloating Severity Questionnaire (BSQ-M). It consists of two components: five-item Sev24 and seven-item SevGen. The responses were in a multiple-choice answer format on different degrees of effect towards individuals on the basis of intensity, frequency and severity (less severe to more severe; range 1 to 4,5,6,7 or 8 varied by items). Higher scores in BSQ indicate worse severity.

Secondary Outcome Measures

Health belief
Measured using the Malay-Language Health of Bloating (HB-Bloat) Scale. The questionnaire consists of 12 items and 3 domains: attitude (3 items), subjective norm (5 items), perceived control towards self-management (4 items). All responses were measured on a five-point Likert scale from 1 (strongly disagree) to 5 (strongly agree).
Health seeking Intention
Measured using Health Seeking Intention for Abdominal Bloating Scale. It is a 5 point Likert scale that consists of 1 domain and 1 item. 1 indicates "strongly diagree" while 5 indicates "strongly agree"
Health promoting behavior
Measured using Health Promoting Behavior Scale of Abdominal Bloating. The questionnaire consists of 4 domains and 15 items. The questionnaire is a 5 point Likert scales, whereby 1 is considered strongly disagree and 5 is considered strongly agree.
Anxiety
Measured using the Malay version of Hospital Anxiety and Depression Scale (HADS). It comprises of 14 items, seven of which is related to anxiety symptoms. Each item is coded from 0 to 3. The scores for anxiety and depression can therefore vary from 0 to 21, depending on the presence and severity of the symptoms. A score between 0 and 7 does not indicate the presence of the symptoms of anxiety; a score between 8 and 10 indicates the presence of a moderate symptom; a score of 11 and above indicates a significant number of symptoms of anxiety corresponding to confirmed cases.
Depression
Measured using the Malay version of Hospital Anxiety and Depression Scale (HADS). It comprises of 14 items, seven of which is related to anxiety symptoms. Each item is coded from 0 to 3. The scores for anxiety and depression can therefore vary from 0 to 21, depending on the presence and severity of the symptoms. A score between 0 and 7 does not indicate the presence of the symptoms of anxiety; a score between 8 and 10 indicates the presence of a moderate symptom; a score of 11 and above indicates a significant number of symptoms of anxiety corresponding to confirmed cases.
Abdominal circumference
Using a non-stretch metric tape
Electrical activity
Measured using the Megawin ME6000 Electromyograph
Quality of life for patients with abdominal bloating
Measured using the Malay version of Bloating Quality of Life (BLQoL-M) Questionnaires. The responses for BLQoL were in a 7-point Likert scale on different degrees of impact towards individual ranging from 1 = "never/not related to me" to 7 = "always". Higher scores in BLQoL indicate higher impact towards QoL.

Full Information

First Posted
February 25, 2021
Last Updated
November 4, 2022
Sponsor
Universiti Sains Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04789967
Brief Title
Effects of Imagery Therapy vs Progressive Muscle Relaxation Therapy on Patients With Functional Abdominal Bloating
Official Title
The Effects of Imagery Treatments vs Progressive Muscle Relaxation Therapy in Terms of Clinical, Psychological and Physiological Aspects Among Patients With Functional Abdominal Bloating
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
65% of the general population reported experiencing moderate to severe bloating symptoms. Bloating could be disturbing to patients and frustrating to the physicians as an effective treatment is still lacking. Guided Imagery (GI) involves the structured visualisation of mental images with somatic sensory; whereas Progressive Muscle Relaxation (PMR) focuses on tightening and relaxing the body's specific muscle groups. The development and validation of GI or PMR interventions to treat patients with functional abdominal bloating are relatively novel.
Detailed Description
The baseline variables of the patient would be obtained at the outpatient Gastrointestinal Medical clinic. A thorough general clinical interview that encompasses medical and psychological history, discussion of the nature and severity of the current symptoms, and review of past treatments and conclusions of any medical evaluation and tests. This is to make sure that the patients have been comprehensively evaluated medically and to rule out other causes of abdominal bloating before reaching a firm diagnosis of functional abdominal bloating as suggested in ROME IV Criteria. Questionnaires will be given out and patients were asked to fill it up on the spot. Electrical activity and abdominal circumference would be measured at an enclosed space with appropriate privacy and accompanied by a chaperone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders
Keywords
Guided Imagery, Progressive Muscle Relaxation, Relaxation Techniques, Psychotherapy, Hypnosis, Sports Psychology, Bloating, Gastrointestinal Disease, Distention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided Imagery (GI)
Arm Type
Active Comparator
Arm Description
A 8 minute audio that focuses on evoking mental images in reducing the abdominal bloating sensation in patients
Arm Title
Progressive Muscle Relaxation (PMR)
Arm Type
Active Comparator
Arm Description
A 8 minute audio that focuses on contracting certain muscle groups and relaxing it progressively in reducing the abdominal bloating sensation in patients
Arm Title
Audiobook
Arm Type
Placebo Comparator
Arm Description
A 8 minute audio that focuses on providing educational information regarding functional gastrointestinal disorders and related knowledge.
Intervention Type
Behavioral
Intervention Name(s)
Guided Imagery
Other Intervention Name(s)
Imagery (Psychotherapy), Imagery, Guided, Psychotherapy Imagery, Imagery Psychotherapy
Intervention Description
Individualized Guided Imagery (GI) technique, an alternative type of relaxation therapy. The content of GI usually includes scenery, places or any image projected to the mind. By using information generated, participants are guided to create a place in their mind using their senses of touch, sound, smell, sight and taste.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation
Other Intervention Name(s)
Progressive Relaxation
Intervention Description
Progressive muscle relaxation (PMR) therapy works by progressively relaxing and tensing the muscle groups throughout the entire body. Each muscle group will be tensed for about 5 seconds. If there's any pain or discomfort at any of the targeted areas, participants were told to omit that particular step. Constant purposeful deep breathing was instructed throughout the session especially in between changes of muscle.
Intervention Type
Other
Intervention Name(s)
Educational Audiobook
Intervention Description
Participants in the control group will receive an audiobook that targets to educate patients regarding gut-brain disorders, functional gastrointestinal disorders, causes of functional abdominal bloating, and treatment modalities available. Relaxing musical background will be added to facilitate the delivery.
Primary Outcome Measure Information:
Title
Symptoms severity
Description
Measured using the Malay version of Bloating Severity Questionnaire (BSQ-M). It consists of two components: five-item Sev24 and seven-item SevGen. The responses were in a multiple-choice answer format on different degrees of effect towards individuals on the basis of intensity, frequency and severity (less severe to more severe; range 1 to 4,5,6,7 or 8 varied by items). Higher scores in BSQ indicate worse severity.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Health belief
Description
Measured using the Malay-Language Health of Bloating (HB-Bloat) Scale. The questionnaire consists of 12 items and 3 domains: attitude (3 items), subjective norm (5 items), perceived control towards self-management (4 items). All responses were measured on a five-point Likert scale from 1 (strongly disagree) to 5 (strongly agree).
Time Frame
1 month
Title
Health seeking Intention
Description
Measured using Health Seeking Intention for Abdominal Bloating Scale. It is a 5 point Likert scale that consists of 1 domain and 1 item. 1 indicates "strongly diagree" while 5 indicates "strongly agree"
Time Frame
1 month
Title
Health promoting behavior
Description
Measured using Health Promoting Behavior Scale of Abdominal Bloating. The questionnaire consists of 4 domains and 15 items. The questionnaire is a 5 point Likert scales, whereby 1 is considered strongly disagree and 5 is considered strongly agree.
Time Frame
1 month
Title
Anxiety
Description
Measured using the Malay version of Hospital Anxiety and Depression Scale (HADS). It comprises of 14 items, seven of which is related to anxiety symptoms. Each item is coded from 0 to 3. The scores for anxiety and depression can therefore vary from 0 to 21, depending on the presence and severity of the symptoms. A score between 0 and 7 does not indicate the presence of the symptoms of anxiety; a score between 8 and 10 indicates the presence of a moderate symptom; a score of 11 and above indicates a significant number of symptoms of anxiety corresponding to confirmed cases.
Time Frame
1 month
Title
Depression
Description
Measured using the Malay version of Hospital Anxiety and Depression Scale (HADS). It comprises of 14 items, seven of which is related to anxiety symptoms. Each item is coded from 0 to 3. The scores for anxiety and depression can therefore vary from 0 to 21, depending on the presence and severity of the symptoms. A score between 0 and 7 does not indicate the presence of the symptoms of anxiety; a score between 8 and 10 indicates the presence of a moderate symptom; a score of 11 and above indicates a significant number of symptoms of anxiety corresponding to confirmed cases.
Time Frame
1 month
Title
Abdominal circumference
Description
Using a non-stretch metric tape
Time Frame
1 month
Title
Electrical activity
Description
Measured using the Megawin ME6000 Electromyograph
Time Frame
1 month
Title
Quality of life for patients with abdominal bloating
Description
Measured using the Malay version of Bloating Quality of Life (BLQoL-M) Questionnaires. The responses for BLQoL were in a 7-point Likert scale on different degrees of impact towards individual ranging from 1 = "never/not related to me" to 7 = "always". Higher scores in BLQoL indicate higher impact towards QoL.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants with abdominal bloating as determined using the Malay version Rome III criteria which was validated and translated by past researchers (Lee et al, 2012) and/or patients who were suggested by clinicians. Participants must be 18 years and above, and of either gender. Participants are able to read, write, or understand the Malay language. Exclusion Criteria: Patients with abdominal bloating due to organic disorder Patients with recent abdominal surgeries (within 3 months) or previous major abdominal surgeries Patients with major neurological and psychological disorders including stroke, schizophrenia, major depression. Patients with medical history which may be the red flag for other FGIDs and organic disorders . Patients who are on psychotropic medications or psychotherapy which may confound outcome of imagery of sham intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Tee, MD
Organizational Affiliation
Universiti Sains Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Sains Malaysia
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Imagery Therapy vs Progressive Muscle Relaxation Therapy on Patients With Functional Abdominal Bloating

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