NCT07339293

The Effect of Constipation Insoles on the Management of Constipation

Constipation Insoles

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Istanbul Aydın University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Palliative Care
• Constipation

Interventions

Type	Name	Description
BEHAVIORAL	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
BEHAVIORAL	Walk	Patients in the control group were only instructed to walk for 20 minutes a day for four weeks

Timeline

• Start date: 2024-01-10
• Primary completion: 2024-11-30
• Completion: 2024-12-30
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

1 site across 1 country: Turkey (Türkiye)