NCT05805787

Brief Summary

This study will carried out to determine the effect of acupressure applied to Tianshu (ST25), Guanyuan (CV4) and Hegu (LI4) acupuncture points for a total of 6 minutes, two to each point, on the symptoms of constipation in the elderly people receiving institutional care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

March 26, 2023

Last Update Submit

April 11, 2023

Conditions

Keywords

elderlydefecationlaxativesold age homes

Outcome Measures

Primary Outcomes (2)

  • Constipation Assessment Scale

    It will be used to evaluate the symptoms of constipation.Constipation Assessment Scale prepared according to the Rome IV criteria for the diagnosis of constipation. According to the criteria, 2 or more of the following symptoms must have started at least 6 months ago and continued for the last 3 months. i. Straining more than 25% of defecations. ii. Lumpy or hard stools (The Bristol Stool Form Scale type 1 or 2) more than 25% of defecations. iii. Sensation of incomplete evacuation more than one-fourth (25%) of defecations. iv. Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations. v. Manual maneuvers to facilitate more than one-fourth (25%) of defecations. vi. Fewer than three spontaneous bowel movements per week

    Change from Baseline symptoms of constipation at 24 days

  • Bristol Stool Scale

    It will be used to determine the characteristics of the stool. This helps assess how long the stool has spent in the bowel. Types 1 and 2 indicate an unusually hard stool and constipation. types 6 and 7 are unusually loose and may indicate diarrhea. A normal stool should be a type 3, 4, and 5.

    Change from Baseline symptoms of constipation at 24 days

Secondary Outcomes (1)

  • Number of Defecation

    Change from baseline number of defecations at 24 days

Study Arms (2)

Acupressure group

EXPERIMENTAL

Acupressure will be applied to the elderly in the experimental group once a day, 5 days a week (Monday-Friday) for a week. The application will last for 2 weeks. A total of 10 sessions of acupressure will be applied. Acupressure application will be applied by researchers who have been trained and certified on this subject. While the elderly are in supine position, pressure will be applied to each acupressure point, respectively, Tianshu (ST25), Guanyuan (CV4) and Hegu (LI4) for 2 minutes for a total of 6 minutes.

Other: Acupressure

Control group

NO INTERVENTION

No intervention will be applied

Interventions

Acupressure will be applied to the elderly in the experimental group once a day, 5 days a week (Monday-Friday) for a week. The application will last for 2 weeks. A total of 10 sessions of acupressure will be applied. Acupressure application will be applied by researchers who have been trained and certified on this subject. While the elderly are in supine position, pressure will be applied to each acupressure point, respectively, Tianshu (ST25), Guanyuan (CV4) and Hegu (LI4) for 2 minutes for a total of 6 minutes.

Acupressure group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 60 and over,
  • Experiencing two or more of the Rome IV criteria
  • Not following a special nutrition program
  • Not using laxatives

You may not qualify if:

  • Have a communication problem
  • Having high cognitive impairment (according to the Mini-Cog test)
  • Addicted to bed
  • Having musculoskeletal problems (eg amputation of the acupuncture site)
  • Having received acupressure / acupuncture treatment up to 8 weeks before the study
  • Having skin problems at acupressure points (eg, skin rash, infection)
  • History of gastrointestinal disorders such as irritable bowel syndrome, rectal prolapse, anal fissure, volvulus, and bowel obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yalova University

Yalova, Turkey (Türkiye)

Location

Related Publications (2)

  • Abbasi P, Mojalli M, Kianmehr M, Zamani S. Effect of acupressure on constipation in patients undergoing hemodialysis: A randomized double-blind controlled clinical trial. Avicenna J Phytomed. 2019 Jan-Feb;9(1):84-91.

  • Ho MH, Chang HCR, Liu MF, Yuan L, Montayre J. Effectiveness of acupoint pressure on older people with constipation in nursing homes: a double-blind quasi-experimental study. Contemp Nurse. 2020 Oct-Dec;56(5-6):417-427. doi: 10.1080/10376178.2020.1813042. Epub 2020 Sep 18.

MeSH Terms

Conditions

Constipation

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Esra Usta, PhD

    University of Yalova

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized, pretest-posttest control group study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2023

First Posted

April 10, 2023

Study Start

April 1, 2023

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations