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Irritable Bowel Syndrome With DiarrheaNCT05702255

Self- Administered Acupressure for Diarrhea Predominant Irritable Bowel Syndrome

A study testing Active acupressure in people with Irritable Bowel Syndrome With Diarrhea, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to assess the effect of active self- administered acupressure compared to sham self- administered acupressure on the health outcome for patient with diarrhea predominant Irritable Bowel Syndrome Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Irritable Bowel Syndrome With Diarrhea
What is being tested?
Active acupressure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteEgypt
Study dates
5 Feb 2023to 28 Aug 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with diarrhea irritable bowel syndrome symptoms following Rome IV diagnostic criteria
  • Agreed to be on a fixed dose of the pharmacological therapy throughout the study

Who cannot join

  • Patients with severe lesions in major organs such as the heart, liver, and kidney, hematopoietic diseases, or tumors
  • Eating disorders
  • History of major abdominal surgery
  • History of neurological and mental illness
  • Usage of other treatment rather than the medical treatment regularly 2 weeks before randomization and throughout the study
  • Previous history of drug or alcohol abuse 6 months before randomization
Show all 10Show fewer
  • Pregnant and lactating women.
  • Patient reporting of adequate relief of their irritable bowel syndrome symptoms the week preceding the randomization
  • Patient has too mild symptoms ( obtaining less than 75 on Irritable bowel syndrome symptoms severity scale at the baseline assessment)
  • Currently participating in other clinical trials

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • outpatient clinics of Main University Hospital

    Alexandria

Other trials in Egypt

About this study

Official title: Effect of Self- Administered Acupressure on Diarrhea Predominant Irritable Bowel Syndrome Patients' Health Outcomes: a Double Blind- Sham Controlled Randomized Clinical Trial

This study aims to assess the effect of active self- administered acupressure compared to sham self- administered acupressure on the health outcome for patient with diarrhea predominant Irritable Bowel Syndrome

Read the detailed description

Research suggests promising benefits of acupuncture in terms of symptom control and quality of life improvements in patients with irritable bowel syndrome. but the cost of the needle and the invasive nature of the procedure decreases patient compliance with acupuncture. in this respect, acupressure can be taught to patients to allow them to perform it themselves, instead of being administered by practitioners. Self-administered acupressure is less time-intensive, low-cost, and flexible to perform. Nurses involved in irritable bowel syndrome patient care play an active role in the practitioner-patient relationship By assessing the specific symptoms that are present, determining the severity of symptoms and the impact on the irritable bowel syndrome patient's life, and being knowledgeable of available treatment options, the nurse involved in irritable bowel syndrome care becomes an essential conduit of information and a valuable facilitator of a positive practitioner-patient therapeutic relationship. In this way, nurses can help to limit the negative consequences of this common disorder and improve overall treatment outcomes in this population. . Thus this study will be conducted to assess the effectiveness of active self-administered acupressure on diarrhea-predominant irritable bowel syndrome

Being tested
Active acupressure, Sham acuptressure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active acupressureOther

    Participants will receive training (2 sessions, 2 days a part) by a training researcher. Patients will be taught on the acupoints location and the acupressure technique. Participants will be verified for the correct location of the acupoints, acupressure technique and strength. Participants will be instructed to use thumb or middle finger to self- press each acupoint using circular movements. The force of pressing must be sufficiently strong but still within a comfortable range. A lubricant will be uses to decrease friction between the acupoints and the finger. Follow up evaluation will be at the end of the week 2 and week 4 .The training researcher will make weekly calls to remind participants to perform acupressure and to answer questions

  • Sham acuptressureOther

    The same protocol as the active acupressure group.

Study groups in NCT05702255
Study groupRoleWhat they receive
Active acupoints groupExperimentalAll participants in the active group will be treated with basic acupoints Zhongwan (CV 12), Tianshu (ST25) in alternation with Sanyinjiao (SP 6), Zusanli (ST 36). Moreover according to traditional Chinese medicine diagnosis, additional acupoints will be added. The frequency of acupressure treatment will be twice a day for 4 weeks, in total 56 sets.
Receives: Other: Active acupressure
Sham acupoints groupSham comparatorAll participants on the sham acupoints group will recieive sham Zhongwan (CV 12), sham Tianshu (ST25), sham Sanyinjiao (SP 6), and sham Zusanli (ST 36) acupressure. All the sham points are 2 cm outside and parallel to the actual points which do not match any recognized acupuncture points and are thought to have no therapeutic effect. The frequency of acupressure treatment will be twice a day for 4 weeks, in total 56 sets.
Receives: Other: Sham acuptressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline mean of irritable Bowel Syndrome Symptom Severity Score

    It is five item questionnaire measuring frequency and intensity of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and the interference of IBS with daily life. Subjects respond to each question on a 100-point visual analogue scale. The total score ranges from 0 to 500. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (>300) disease

    Measured: Immediately before assigning the participants to the study groups

  2. Change from the baseline irritable Bowel Syndrome Symptom Severity Score at 2 weeks

    t is five item questionnaire measuring frequency and intensity of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and the interference of IBS with daily life. Subjects respond to each question on a 100-point visual analogue scale. The total score ranges from 0 to 500. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (>300) disease

    Measured: after 2 weeks from the baseline

  3. Change from the baseline irritable Bowel Syndrome Symptom Severity Score at 4 weeks

    t is five item questionnaire measuring frequency and intensity of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and the interference of IBS with daily life. Subjects respond to each question on a 100-point visual analogue scale. The total score ranges from 0 to 500. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (>300) disease

    Measured: after 4 weeks from the baseline

  4. Irritable Bowel Syndrome Adequate Relief question

    It is a dichotomous single item that asks participants "Over the past week have you had adequate relief of your irritable Bowel Syndrome symptoms?" . A responder was defined as a patient who answered this question affirmatively.

    Measured: At the baseline

  5. Irritable Bowel Syndrome Adequate Relief question

    It is a dichotomous single item that asks participants "Over the past week have you had adequate relief of your irritable Bowel Syndrome symptoms?" . A responder was defined as a patient who answered this question affirmatively.

    Measured: After 2 weeks from the baseline

  6. Irritable Bowel Syndrome Adequate Relief question

    It is a dichotomous single item that asks participants "Over the past week have you had adequate relief of your irritable Bowel Syndrome symptoms?" . A responder was defined as a patient who answered this question affirmatively.

    Measured: After 4 weeks from the baseline

  7. Mean stool frequency after 2 weeks

    Defined by the bi-weekly change of frequency of defecation,patient will report the number of defecation per day to calculate it.

    Measured: After 2 weeks from the patient endorsement

  8. Mean change of stool frequency after 4 weeks

    Defined by the bi-weekly change of frequency of defecation,patient will report the number of defecation per day to calculate it.

    Measured: After 4 weeks from the patient endorsement

  9. Stool consistency

    Defined by the Bristol Stool Form Scale, It is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7). Types 1 and2 are considered to be abnormally hard stools while Types 6 and 7 are considered abnormally loose/liquid stools. Type 3, 4 and 5 are considered to be the most normal stool type

    Measured: at the baseline

  10. Change in the frequency of stool consistency at 2 weeks from the baseline

    defined by the Bristol Stool Form Scale

    Measured: after 2 weeks from baseline

  11. Change in the frequency of stool consistency at 4 weeks from the baseline

    Defined by the Bristol Stool Form Scale, It is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7). Types 1 and2 are considered to be abnormally hard stools while Types 6 and 7 are considered abnormally loose/liquid stools. Type 3, 4 and 5 are considered to be the most normal stool type

    Measured: after 4 weeks

Secondary outcomes (8)
  1. Demographic and clinical data

    A questionnaire will be developed to collect data about participants' age, gender, body mass index, physical activity status, diet, smoking status, medication used.

    Measured: before assignment of the participants to the study groups

  2. the baseline mean of psychological distress measured by the Hospital Anxiety and Depression Scale

    the scale contains 14 items, seven statements on each sub-scale which assess symptoms experienced during the past week on four-point rating scale (0 to 3); a higher score depicts a worse condition. For each sub-scale the maximum score is 21. A score of ≥11 is considered a clinically significant disorder, whereas a score between 8 and 10 suggests a mild disorder

    Measured: at the baseline

  3. Change from the baseline mean of the psychological distress measured by the Hospital Anxiety and Depression Scale at 4 weeks

    the scale contains 14 items, seven statements on each sub-scale which assess symptoms experienced during the past week on four-point rating scale (0 to 3); a higher score depicts a worse condition. For each sub-scale the maximum score is 21. A score of ≥11 is considered a clinically significant disorder, whereas a score between 8 and 10 suggests a mild disorder

    Measured: after 4 weeks from the baseline

  4. Baseline mean of the quality of Life

    it will be measured by the irritable bowel syndrome quality of Life questionnaire. It consists of 34 items that assess the degree to which irritable bowel syndrome disturbed quality of life for a subject over the past 30 days through eight sub-scales. Each item is rated on a 5-point scale ranging from 1 to 5 with higher values indicating a lower quality of life.

    Measured: at the baseline

  5. Change from the baseline mean of the quality of life at 4 weeks

    it will be measured by the irritable bowel syndrome quality of Life questionnaire. It consists of 34 items that assess the degree to which irritable bowel syndrome disturbed quality of life for a subject over the past 30 days through eight sub-scales. Each item is rated on a 5-point scale ranging from 1 to 5 with higher values indicating a lower quality of life.

    Measured: Four weeks after the baseline assessment

  6. Related adverse Events

    An unfavorable change in the health of a participants that happens during a clinical study or within a week after the study has ended. This change may or may not be caused by the acupressure.

    Measured: from the patients endorsement till one week after study completion

  7. Adherence to the to active and sham self-administered acupressure of the study.

    The adherence will be calculated as percentage of planned sessions of acupressure, and adherence rate above 80% was set as a minimum requirement to be regarded as acceptable

    Measured: throughout study completion, an average of 4 months

  8. use of rescue medicine

    participants will be asked to report the use of rescue medicine for diarrhea or gastrointestinal symptoms

    Measured: throughout study completion, an average of 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start5 Feb 2023
  3. Primary completion28 Aug 2023
  4. Study completion28 Aug 2023

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05702255
Sponsor's protocol ID
2022-9-55
Status last verified
Apr 2024
First submitted
7 Jan 2023
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Asal MGR, El-Sayed AAI, Alsenany SA, Ramzy ZH, Dawood RFA. Self-administered active versus sham acupressure for diarrhea predominant irritable bowel syndrome: a nurse-led randomized clinical trial. BMC Nurs. 2025 Jan 28;24(1):106. doi: 10.1186/s12912-024-02594-5.

    PubMed 39875940

Questions about this trial

What is this clinical trial studying?

A study testing Active acupressure in people with Irritable Bowel Syndrome With Diarrhea, run by Alexandria University at 1 site in Egypt.

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 2 inclusion and 10 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 30 Apr 2024. 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 Egypt. 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?

Baseline mean of irritable Bowel Syndrome Symptom Severity Score (time frame: Immediately before assigning the participants to the study groups). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05702255, which also lists 1 linked publication.

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 30 Apr 2024.

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