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The Effect of Constipation Insoles on the Management of Constipation

Constipation Insoles

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07339293
Enrollment
139
Registered
2026-01-14
Start date
2024-01-10
Completion date
2024-12-30
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palliative Care, Constipation

Keywords

constipation, palliative care, reflexology, nursing, comfort

Brief 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.

Interventions

BEHAVIORALconstipation 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

BEHAVIORALWalk

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

Sponsors

The Scientific and Technological Research Council of Turkey
CollaboratorOTHER
Istanbul Aydın University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Constipation Severity ScaleFirst weekThe Large Bowel Syndrome (LBS) consists of 16 questions in total and was developed to determine the frequency, intensity, and difficulty during defecation. The LBS comprises three sub-dimensions: large bowel sluggishness, fecal obstruction, and pain. The highest possible score on the scale is 73. Scores for fecal obstruction range from 0-28, for large bowel sluggishness from 0-29, and for pain from 0-16.
Constipation Assessment ScaleBaselineThis is a scale consisting of 8 items in total, which inquires about abdominal bloating, gas, bowel sounds, fecal incontinence, feeling of fullness/pressure in the rectum, pain during defecation, small or lumpy stools, and the presence of an urgent need to defecate but inability to do so.
Overall Comfort ScaleBaselineIt is a scale developed to assess an individual's need for comfort. In the evaluation of the scale, negatively worded items are reverse-coded and summed together with the positively worded items. The highest possible total score on the scale is 192, while the lowest possible total score is 48. The total score obtained is divided by the number of items on the scale to calculate the mean score, which is expressed on a scale ranging from 1 to 4. A score of 1 indicates low comfort, whereas a score of 4 indicates high comfort.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026