NCT06875349

Brief Summary

to determine and compare the effects of foot reflexology and abdominal massage applied to elderly individuals on constipation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

12 months

First QC Date

February 20, 2025

Last Update Submit

March 9, 2025

Conditions

Keywords

constipationreflexologyabdominal massagerandomised

Outcome Measures

Primary Outcomes (3)

  • Constipation Severity Scale

    Does foot reflexology have an effect on constipation in elderly individuals? Constipation Severity Scale: The total score range is 0-73, with higher scores indicating greater severity of constipation.

    Day 1 and Day 13 and Day 25

  • Constipation Severity Scale

    Does abdominal massage have an effect on constipation in elderly individuals? Constipation Severity Scale: The total score range is 0-73, with higher scores indicating greater severity of constipation.

    Day 1 and Day 13 and Day 25

  • Constipation Severity Scale

    Is there a difference between the effects of foot reflexology and abdominal massage on constipation in elderly individuals? Constipation Severity Scale: The total score range is 0-73, with higher scores indicating greater severity of constipation.

    Day 1 and Day 13 and Day 25

Study Arms (3)

Group 1: Foot Reflexology

EXPERIMENTAL

In the experimental group-1, foot reflexology interventions were applied every three days, with each session lasting 30 minutes, for a total of eight sessions.

Other: foot reflexology

Group 2: Abdominal Massage

EXPERIMENTAL

In the experimental group-2, abdominal massage interventions were applied every three days, with each session lasting 30 minutes, for a total of eight sessions.

Other: abdominal massage

Group 3: Control

NO INTERVENTION

The elderly individuals in the control group did not receive any intervention and were only monitored.

Interventions

Foot reflexology is a complementary therapy that involves applying pressure to specific points on the feet, which are believed to correspond to different organs and systems in the body. This technique aims to promote healing by improving blood circulation, reducing stress, and supporting overall well-being. Reflexology is often used to help with issues such as constipation, stress, sleep disorders, and pain management.

Group 1: Foot Reflexology

Abdominal massage is a therapeutic technique that involves applying gentle pressure and circular motions to the abdominal area to stimulate digestion, improve bowel movements, and relieve discomfort. It is commonly used to help with issues such as constipation, bloating, and digestive disorders by promoting intestinal motility and blood circulation. This technique can be performed manually or with the help of tools and is often incorporated into holistic and nursing care practices.

Group 2: Abdominal Massage

Eligibility Criteria

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

You may qualify if:

  • Being 65 years or older Having no movement restrictions Not using pharmacological laxatives Being diagnosed with constipation according to the ROMA IV criteria Voluntarily agreeing to participate in the study

You may not qualify if:

  • Individuals having a condition that prevents cognitive, affective and verbal communication Having a disorder related to the nervous system and circulatory system Having an injection applied to the abdominal region during the application process Having a systematic disorder related to the GIS (diarrhea, irritable bowel syndrome, fecal impaction, incontinence, etc.) Having physiological and structural disorders that may prevent evacuation in the anus region (rectal fissure, etc.) Having any negativity in the sensory function examination test performed with a sharp-blunt hard object on the sole of the foot and abdomen Having any physiological and structural disorders related to the foot/sole of the foot

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor in nursing fundamentals department

Study Record Dates

First Submitted

February 20, 2025

First Posted

March 13, 2025

Study Start

January 1, 2024

Primary Completion

December 30, 2024

Study Completion

February 19, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations