Self- Administered Acupressure for Diarrhea Predominant Irritable Bowel Syndrome

NCT ID: NCT05702255

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-05
• Study Completion Date: 2023-08-28

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

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

Conditions

Irritable Bowel Syndrome With Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Active acupoints group

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.

Group Type: EXPERIMENTAL

Active acupressure

Intervention Type: 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

Sham acupoints group

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.

Group Type: SHAM_COMPARATOR

Sham acuptressure

Intervention Type: OTHER

The same protocol as the active acupressure group.

Interventions

Active acupressure

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

Intervention Type: OTHER

Sham acuptressure

The same protocol as the active acupressure group.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Maha Gamal Ramadan Asal

Principle investgator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maha G Asal, Phd

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Zahraa H Ramzy, Phd

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Rasha F Ahmed, Phd

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

outpatient clinics of Main University Hospital

Alexandria, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 39875940 (View on PubMed)

Other Identifiers

2022-9-55

Identifier Type: -

Identifier Source: org_study_id