NCT05506397

Brief Summary

This study was carried out to determine the effect of acupressure applied to LI4, CV12, ST25 and ST36 acupuncture points for a total of 21 minutes, three to each point, on the symptoms of constipation and quality of life of elderly individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

July 23, 2022

Last Update Submit

August 17, 2022

Conditions

Constıpatıon

Keywords

AcupressureConstipationQuality of lifeElderly peopleNursing

Outcome Measures

Primary Outcomes (1)

  • Constipation Assessment Scale (CAS)

    It was used to evaluate the symptoms of constipation.

    Change from Baseline symptoms of constipation at 12 days

Secondary Outcomes (3)

  • Constipation Quality of Life Scale (PAC-QOL)

    Change from baseline constipation-related quality of life at 12 days

  • Visual Analog Scale (VAS)

    Change from baseline defecation comfort at 12 days

  • Number of Defecation

    Change from baseline number of defecations at 12 days

Study Arms (2)

Acupressure (intervention group)

EXPERIMENTAL

Acupressure was applied to individuals in the acupressure group every day for 12 days.

Other: Acupressure

control group

PLACEBO COMPARATOR

Placebo acupressure was applied to the individuals in the placebo acupressure group in accordance with the same protocol.

Other: Acupressure

Interventions

AcupressureOTHER

Acupressure is a technique based on stimulating certain points on the body with stimulation methods such as hands and fingers.

Acupressure (intervention group)control group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65 and over,
  • Able to answer cognitive questions
  • Able to do daily tasks unaided
  • Experiencing two or more of the Rome IV criteria

You may not qualify if:

  • Communication and adaptation difficulties,
  • Malignant, intestinal obstruction, fecal incontinence, diarrhea, irritable bowel syndrome, abdominal infection, etc. have a contraindication to continue the intervention, addicted to bed
  • Chronic pain requiring long-term analgesic intake and using psychiatric medication,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, Kayseri̇, 38280, Turkey (Türkiye)

Location

Related Publications (5)

  • Shin J, Park H. Effects of Auricular Acupressure on Constipation in Patients With Breast Cancer Receiving Chemotherapy: A Randomized Control Trial. West J Nurs Res. 2018 Jan;40(1):67-83. doi: 10.1177/0193945916680362. Epub 2016 Nov 30.

    PMID: 27903827BACKGROUND

  • Wang PM, Hsu CW, Liu CT, Lai TY, Tzeng FL, Huang CF. Effect of acupressure on constipation in patients with advanced cancer. Support Care Cancer. 2019 Sep;27(9):3473-3478. doi: 10.1007/s00520-019-4655-1. Epub 2019 Jan 24.

    PMID: 30675666BACKGROUND

  • Jung ES, Chang AK. Effects of Auricular Acupressure in Patients on Hemodialysis. J Nurs Res. 2020 Aug;28(4):e106. doi: 10.1097/jnr.0000000000000378.

    PMID: 32379107BACKGROUND

  • Lee EJ, Frazier SK. The efficacy of acupressure for symptom management: a systematic review. J Pain Symptom Manage. 2011 Oct;42(4):589-603. doi: 10.1016/j.jpainsymman.2011.01.007. Epub 2011 Apr 30.

    PMID: 21531533RESULT

  • Aydemir T, Tasci S, Bayraktar M, Saz A. The effect of acupressure on constipation symptoms and quality of life among older people: a mixed-methods study. Eur Geriatr Med. 2023 Oct;14(5):1135-1144. doi: 10.1007/s41999-023-00842-6. Epub 2023 Jul 21.

    PMID: 37477804DERIVED

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

  • Sultan TAŞCI, Prof. Dr.

    TC Erciyes University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
A double-blind design was applied, including participants, interviewers and outcomes assessors.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized, placebo-controlled, pretest-posttest control group study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2022

First Posted

August 18, 2022

Study Start

February 24, 2021

Primary Completion

June 30, 2021

Study Completion

November 30, 2021

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Study Protocol

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
unlimited
Access Criteria
unlimited

Available IPD Datasets

Clinical Study Report Access

Locations

TU(1)