The Effect of Constipation Insoles on the Management of Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2024-12-30

Brief Summary

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Constipation is a common symptom among patients receiving palliative care and significantly affects their quality of life. Effective management of constipation requires both pharmacological and non-pharmacological approaches. Reflexology has been increasingly used as a complementary method for constipation management; however, factors such as the need for a trained reflexology specialist, time limitations, and financial constraints may limit patients' access to this intervention. To overcome these barriers, a constipation insole based on reflexology principles has been developed, which can be easily used by patients either at home or in clinical settings.

This study was designed as a randomized controlled experimental trial to evaluate the effectiveness of a constipation insole in the management of constipation in patients receiving palliative care. During the first week of the study, no intervention was applied in order to assess participants' baseline bowel habits. Starting from the second week, patients in the experimental group were instructed to walk with the constipation insole for 20 minutes per day for a total of four weeks. Patients in the control group were instructed to walk for 20 minutes per day for the same duration, without using the insole.

At baseline, data were collected using the Patient Identification Form and the General Comfort Scale. Throughout the study period, bowel function and constipation-related outcomes were monitored using standardized measurement tools. The Constipation Assessment Scale was planned to be administered every three days, the Constipation Severity Scale daily, and the Bristol Stool Consistency Scale at each defecation. The General Comfort Scale was planned to be re-administered on the 28th day of the intervention period.

The findings obtained from this study are expected to provide evidence regarding the potential role of constipation insoles as a complementary intervention in constipation management for patients in palliative care.

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Detailed Description

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Conditions

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Palliative Care Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental Group

Patients in the experimental group were instructed to walk with the constipation insole for 20 minutes a day for four weeks, starting from the second week

Group Type EXPERIMENTAL

constipation insole

Intervention Type BEHAVIORAL

Patients in the experimental group were instructed to walk with the constipation insole for 20 minutes a day for four weeks, starting from the second week

Walk

Intervention Type BEHAVIORAL

Patients in the control group were only instructed to walk for 20 minutes a day for four weeks

Control Group

Patients in the control group were only instructed to walk for 20 minutes a day for four weeks.

Group Type OTHER

Walk

Intervention Type BEHAVIORAL

Patients in the control group were only instructed to walk for 20 minutes a day for four weeks

Interventions

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constipation insole

Patients in the experimental group were instructed to walk with the constipation insole for 20 minutes a day for four weeks, starting from the second week

Intervention Type BEHAVIORAL

Walk

Patients in the control group were only instructed to walk for 20 minutes a day for four weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients who volunteer to participate in the study and are over 18 years of age,
* Patients without any cognitive, mental, or verbal communication impairments,
* Patients receiving palliative care,
* Patients with constipation,
* Patients with fewer than 3 bowel movements per week and/or at least one of the following constipation problems (straining during bowel movements, hard stools, feeling of incomplete emptying, gas/bloating, pressure/feeling of needing to defecate in the rectum).

Exclusion Criteria

* Individuals with peripheral neuropathy,
* impaired foot skin integrity,
* flat feet or any foot deformity,
* and those using complementary treatments such as abdominal massage, acupressure, or acupuncture to relieve constipation were excluded from the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes