Functional Gastrointestinal DisordersNCT04789967
Effects of Imagery Therapy vs Progressive Muscle Relaxation Therapy on Patients With Functional Abdominal Bloating
A study testing Guided Imagery, Progressive Muscle Relaxation and Educational Audiobook in people with Functional Gastrointestinal Disorders, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- Guided Imagery, Progressive Muscle Relaxation and Educational Audiobook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteMalaysia
- Study dates
- 25 Feb 2021to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Guided Imagery, Progressive Muscle Relaxation, Educational Audiobook
- Keywords
- Guided Imagery, Progressive Muscle Relaxation, Relaxation Techniques, Psychotherapy, Hypnosis, Sports Psychology, Bloating, Gastrointestinal Disease, Distention
- Medical subject headings
- Gastrointestinal Diseases, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryBehavioural
Also called Imagery (Psychotherapy), Imagery, Guided, Psychotherapy Imagery, Imagery Psychotherapy
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 RelaxationBehavioural
Also called Progressive 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.
Educational AudiobookOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Guided Imagery (GI) | Active comparator | A 8 minute audio that focuses on evoking mental images in reducing the abdominal bloating sensation in patients Receives: Behavioral: Guided Imagery |
| Progressive Muscle Relaxation (PMR) | Active comparator | A 8 minute audio that focuses on contracting certain muscle groups and relaxing it progressively in reducing the abdominal bloating sensation in patients Receives: Behavioral: Progressive Muscle Relaxation |
| Audiobook | Placebo comparator | A 8 minute audio that focuses on providing educational information regarding functional gastrointestinal disorders and related knowledge. Receives: Other: Educational Audiobook |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (8)
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).
Measured: 1 month
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"
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
Abdominal circumference
Using a non-stretch metric tape
Measured: 1 month
Electrical activity
Measured using the Megawin ME6000 Electromyograph
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start25 Feb 2021
- Primary completion28 Jun 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent Tee Wei Shen, Universiti Sains Malaysia
- Investigators
- Vincent Tee, MD, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789967
- Sponsor's protocol ID
- USM/JEPeM/20110562
- Status last verified
- Nov 2022
- First submitted
- 25 Feb 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04789967
- Acronym / sponsor ID
- USM/JEPeM/20110562
- Conditions
- Functional Gastrointestinal Disorders
- Keywords
- Guided Imagery, Progressive Muscle Relaxation, Relaxation Techniques, Psychotherapy, Hypnosis, Sports Psychology, Bloating, Gastrointestinal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery (GI) | Active comparator | Behavioral: Guided ImageryA 8 minute audio that focuses on evoking mental images in reducing the abdominal bloating sensation in patients |
| Progressive Muscle Relaxation (PMR) | Active comparator | Behavioral: Progressive Muscle RelaxationA 8 minute audio that focuses on contracting certain muscle groups and relaxing it progressively in reducing the abdominal bloating sensation in patients |
| Audiobook | Placebo comparator | Other: Educational AudiobookA 8 minute audio that focuses on providing educational information regarding functional gastrointestinal disorders and related knowledge. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided ImageryAlso: Imagery (Psychotherapy), Imagery, Guided, Psychotherapy Imagery, Imagery PsychotherapyIndividualized 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. | Behavioural | Guided Imagery (GI) |
| Progressive Muscle RelaxationAlso: Progressive RelaxationProgressive 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. | Behavioural | Progressive Muscle Relaxation (PMR) |
| Educational AudiobookParticipants 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. | Other | Audiobook |
Primary outcome
Symptoms severity
Time frame: 1 month
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.
8 secondary outcomes
Health belief
Time frame: 1 month
Health seeking Intention
Time frame: 1 month
Health promoting behavior
Time frame: 1 month
Anxiety
Time frame: 1 month
Depression
Time frame: 1 month
Abdominal circumference
Time frame: 1 month
Electrical activity
Time frame: 1 month
Quality of life for patients with abdominal bloating
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Tee, MD principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery, Progressive Muscle Relaxation and Educational Audiobook in people with Functional Gastrointestinal Disorders, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms severity (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.