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

Universiti Sains Malaysia

Status: Completed

Conditions: Functional Gastrointestinal Disorders

Treatments: Behavioral: Progressive Muscle Relaxation; Other: Educational Audiobook; Behavioral: Guided Imagery

Study type: Interventional

Funder types: Other

Identifiers

NCT04789967

USM/JEPeM/20110562

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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96 participants in 3 patient groups, including a placebo group

Guided Imagery (GI)

Active Comparator group

Description:

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

Treatment:

Behavioral: Guided Imagery

Progressive Muscle Relaxation (PMR)

Active Comparator group

Description:

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

Treatment:

Behavioral: Progressive Muscle Relaxation

Audiobook

Placebo Comparator group

Description:

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

Treatment:

Other: Educational Audiobook