Effects of Imagery Therapy vs Progressive Muscle Relaxation Therapy on Patients With Functional Abdominal Bloating
The Effects of Imagery Treatments vs Progressive Muscle Relaxation Therapy in Terms of Clinical, Psychological and Physiological Aspects Among Patients With Functional Abdominal Bloating
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2021
CompletedStudy Start
First participant enrolled
February 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedNovember 9, 2022
November 1, 2022
1.3 years
February 25, 2021
November 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 month
Secondary Outcomes (8)
Health belief
1 month
Health seeking Intention
1 month
Health promoting behavior
1 month
Anxiety
1 month
Depression
1 month
- +3 more secondary outcomes
Study Arms (3)
Guided Imagery (GI)
ACTIVE COMPARATORA 8 minute audio that focuses on evoking mental images in reducing the abdominal bloating sensation in patients
Progressive Muscle Relaxation (PMR)
ACTIVE COMPARATORA 8 minute audio that focuses on contracting certain muscle groups and relaxing it progressively in reducing the abdominal bloating sensation in patients
Audiobook
PLACEBO COMPARATORA 8 minute audio that focuses on providing educational information regarding functional gastrointestinal disorders and related knowledge.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150, Malaysia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Tee, MD
Universiti Sains Malaysia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
February 25, 2021
First Posted
March 10, 2021
Study Start
February 25, 2021
Primary Completion
June 28, 2022
Study Completion
August 30, 2022
Last Updated
November 9, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share