The Effect of Constipation Insoles on the Management of Constipation

Istanbul Aydın University

Status: Completed

Conditions: Constipation; Palliative Care

Treatments: Behavioral: Walk; Behavioral: constipation insole

Study type: Interventional

Funder types: Other

Identifiers

NCT07339293

Constipation Insoles

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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139 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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

Treatment:

Behavioral: constipation insole

Behavioral: Walk

Control Group

Other group

Description:

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

Treatment:

Behavioral: Walk