Clinical trial NCT04789967: 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
Overall status: COMPLETED
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Keywords: Guided Imagery
Progressive Muscle Relaxation
Relaxation Techniques
Psychotherapy
Hypnosis
Sports Psychology
Bloating
Gastrointestinal Disease
Distention
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Symptoms severity
timeFrame: 1 month
Secondary outcomes:
measure: Health belief
timeFrame: 1 month
measure: Health seeking Intention
timeFrame: 1 month
measure: Health promoting behavior
timeFrame: 1 month
measure: Anxiety
timeFrame: 1 month
measure: Depression
timeFrame: 1 month
measure: Abdominal circumference
timeFrame: 1 month
measure: Electrical activity
timeFrame: 1 month
measure: Quality of life for patients with abdominal bloating
timeFrame: 1 month
Other outcomes:
Locations:
city: Kubang Kerian
country: Malaysia
facility: Universiti Sains Malaysia
state: Kelantan
Study officials:
affiliation: Universiti Sains Malaysia
name: Vincent Tee, MD
role: PRINCIPAL_INVESTIGATOR
References: