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

NCT ID: NCT04789967

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-25
• Study Completion Date: 2022-08-30

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.

Conditions

Functional Gastrointestinal Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Guided Imagery (GI)

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

Group Type: ACTIVE_COMPARATOR

Guided Imagery

Intervention Type: BEHAVIORAL

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)

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

Group Type: ACTIVE_COMPARATOR

Progressive Muscle Relaxation

Intervention Type: BEHAVIORAL

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.

Audiobook

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

Group Type: PLACEBO_COMPARATOR

Educational Audiobook

Intervention Type: OTHER

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.

Interventions

Guided Imagery

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

Progressive Muscle Relaxation

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: BEHAVIORAL

Educational Audiobook

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.

Intervention Type: OTHER

Other Intervention Names

Imagery (Psychotherapy); Imagery, Guided; Psychotherapy Imagery; Imagery Psychotherapy; Progressive Relaxation

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Vincent Tee Wei Shen

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincent Tee, MD

Role: PRINCIPAL_INVESTIGATOR

Universiti Sains Malaysia

Locations

Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia

Countries

Malaysia

Other Identifiers

USM/JEPeM/20110562

Identifier Type: -

Identifier Source: org_study_id