NCT07528534

Brief Summary

This research was planned to evaluate the effects of foot reflexology and acupressure applications on gastrointestinal symptoms in women going through menopause. Menopause is a period in which a woman experiences profound changes in her physiological, psychological, and social life due to the decrease in estrogen and progesterone hormones. Changes in digestive system functions are particularly common during this period; gastrointestinal symptoms such as constipation, bloating, heartburn, indigestion, and abdominal pain significantly reduce the quality of life. The scope of the study focuses on investigating the manageability of these symptoms that occur during menopause with reflexology and acupressure, which are complementary and alternative medicine methods. Reflexology is a method based on the assumption that specific points on the soles of the feet are connected to the relevant organs in the body, aiming to increase blood circulation and regulate organ functions. Acupressure, based on Chinese medicine, aims to regulate energy flow and reduce symptoms by applying finger pressure to specific acupuncture points. Both methods are increasingly recommended for symptom management during menopause due to their non-invasive nature, low side effects, and ease of application. This research will be conducted at Osmaniye State Hospital and will be limited to menopausal women who apply to this institution. Participants' demographic characteristics, duration of menopause, health history, and gastrointestinal symptom levels will be assessed using a Demographic Information Form and the Gastrointestinal Symptom Rating Scale (GSRS). The application process will be carried out in accordance with standard reflexology and acupressure protocols, and changes in symptoms will be analyzed using pre-test and post-test measurements. The study also aims to reveal the effects of gastrointestinal symptoms experienced during menopause on women's quality of life; This study aims to provide evidence-based data on complementary methods that can be integrated into nursing care, in addition to pharmacological treatments. The limited number of studies in the literature addressing the effects of complementary medicine practices during menopause makes this research unique from both a clinical and academic perspective.

Trial Health

65
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Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress37%
Apr 2026Jun 2026

First Submitted

Initial submission to the registry

March 30, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

March 30, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

MenopauseReflexologyAcupressureGastrointestinal symptomsComplementary therapiesWomen's health

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure Change from Baseline in Gastrointestinal Symptom Scores as Measured by the Gastrointestinal Symptom Rating Scale (GSRS)

    Gastrointestinal symptoms will be quantified using the Gastrointestinal Symptom Rating Scale (GSRS), a validated, self-administered questionnaire consisting of 15 items grouped into five domains: abdominal pain, reflux, indigestion, diarrhea, and constipation. Each item is rated on a 7-point Likert scale (1 = no discomfort to 7 = very severe discomfort). Domain scores and total GSRS score will be calculated as the mean of item scores, with higher scores indicating greater symptom severity. The primary endpoint is the change in total GSRS score from baseline to Week 8.

    Baseline and Week 8 (8 weeks)

Study Arms (3)

Foot Reflexology

EXPERIMENTAL
Other: Foot Reflexology

Acupressure

EXPERIMENTAL
Other: Acupressure

control

NO INTERVENTION

Interventions

Menopausal women assigned to the foot reflexology group will receive a standardized reflexology protocol administered by a trained/certified researcher. The steps and standards of the intervention are as follows: Preparation: The application will be conducted in a quiet room with adjusted lighting and temperature. The participant will be positioned on a bed in a supine or semi-sitting position (approximately 45 degrees) with their legs supported. An unscented and non-allergenic massage oil or lotion will be used to reduce friction and maintain skin integrity. Warm-up and Relaxation: Before starting the specific procedure, a brief relaxation massage using effleurage and petrissage techniques will be applied to both feet to increase blood circulation and prepare the tissues. Target Area Applications: Following the warm-up, the focus will be directed to specific reflex points aimed at alleviating gastrointestinal symptoms, which is the primary objective of the study. Using thumb-walkin

Foot Reflexology

Description: Menopausal women assigned to the acupressure group will receive a standardized acupressure protocol administered by a trained/certified practitioner. The steps and standards of the intervention are as follows: Preparation: The application will be conducted in a quiet, well-ventilated room with appropriate lighting and temperature to ensure the participant's comfort. The participant will be placed in a relaxed, comfortable position (supine or seated) that allows the practitioner easy access to the targeted acupressure points. Target Area Applications: The intervention involves applying physical pressure to specific acupuncture points based on Traditional Chinese Medicine principles to regulate energy flow (Qi) and alleviate gastrointestinal symptoms. The practitioner will focus on key acupoints known to support the stomach, intestines, and overall digestive system, as well as points that promote systemic relaxation and autonomic nervous system balance. Application Techni

Acupressure

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between 45 and 60 years of age,
  • Being in menopause,
  • Experiencing gastrointestinal symptoms,
  • Agreeing to participate in the study voluntarily.

You may not qualify if:

  • Individuals with chronic gastrointestinal disease,
  • Individuals receiving regular medication will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Acupressure

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This research will be conducted using a quasi-experimental (pre-test - post-test control group) design. The aim is to measure changes in gastrointestinal symptoms in menopausal women by applying foot reflexology and acupressure for a specific period of time.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 14, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share