Self- Administered Acupressure for Diarrhea Predominant Irritable Bowel Syndrome

NCT05702255 | Completed

• 1 other identifier: 2022-9-55
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Irritable Bowel Syndrome With Diarrhea

Outcome Measures

Primary Outcomes (11)

• 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

  Immediately before assigning the participants to the study groups

• 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

  after 2 weeks from the baseline

• 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

  after 4 weeks from the baseline

• 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.

  At the baseline

• 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.

  After 2 weeks from the baseline

• 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.

  After 4 weeks from the baseline

• 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.

  After 2 weeks from the patient endorsement

• 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.

  After 4 weeks from the patient endorsement

• 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

  at the baseline

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

  defined by the Bristol Stool Form Scale

  after 2 weeks from baseline

• 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

  after 4 weeks

Secondary Outcomes (8)

• Demographic and clinical data

  before assignment of the participants to the study groups

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

  at the baseline

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

  after 4 weeks from the baseline

• Baseline mean of the quality of Life

  at the baseline

• Change from the baseline mean of the quality of life at 4 weeks

  Four weeks after the baseline assessment

Study Arms (2)

Active acupoints group

EXPERIMENTAL

All 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.

Other: Active acupressure

Sham acupoints group

SHAM COMPARATOR

All 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.

Other: Sham acuptressure

Interventions

Active acupressure OTHER

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

Active acupoints group

Sham acuptressure OTHER

The same protocol as the active acupressure group.

Sham acupoints group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

outpatient clinics of Main University Hospital

Alexandria, Egypt

Location

Related Publications (1)

• 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.

  PMID: 39875940 DERIVED

Study Officials

• Maha G Asal, Phd

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Zahraa H Ramzy, Phd

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Rasha F Ahmed, Phd

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: a randomization sequence will be generated by an independent statistician. The randomization list will be recorded and enclosed in sequentially numbered, opaque envelopes. after finishing baseline assessment, the training researcher will open the envelopes to avoid selection bias. only the training researcher will know the group allocation. Participants and other relevant researchers (the outcome evaluator, data managers, and statisticians) will be blinded to the group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investgator

Study Record Dates

• First Submitted: January 7, 2023
• First Posted: January 27, 2023
• Study Start: February 5, 2023
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

EG (1)