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Palliative CareNCT07339293

The Effect of Constipation Insoles on the Management of Constipation

A study testing constipation insole and Walk in people with Palliative Care and Constipation, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Palliative Care, Constipation
What is being tested?
constipation insole and Walk
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jan 2024to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Aydin University

    Istanbul, 34295

Other trials in Turkey (Türkiye)

About this study

Official title: Constipation Insoles

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.

Read more

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.

Being tested
constipation insole, Walk
Keywords
constipation, palliative care, reflexology, nursing, comfort
Medical subject headings
Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • constipation insoleBehavioural

    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

  • WalkBehavioural

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

Study groups in NCT07339293
Study groupRoleWhat they receive
Experimental GroupExperimentalPatients 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
Receives: Behavioral: constipation insole; Behavioral: Walk
Control GroupOtherPatients in the control group were only instructed to walk for 20 minutes a day for four weeks.
Receives: Behavioral: Walk

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Constipation Severity Scale

    The 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.

    Measured: First week

  2. Constipation Severity Scale

    The 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.

    Measured: second week

  3. Constipation Severity Scale

    The 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.

    Measured: third week

  4. Constipation Severity Scale

    The 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.

    Measured: fifth week

  5. Constipation Assessment Scale

    This 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.

    Measured: Baseline

  6. Constipation Assessment Scale

    This 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.

    Measured: third day

  7. Constipation Assessment Scale

    This 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.

    Measured: sixth day

  8. Constipation Assessment Scale

    This 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.

    Measured: ninth day

  9. Constipation Assessment Scale

    This 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.

    Measured: twelfth day

  10. Constipation Assessment Scale

    This 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.

    Measured: fifteenth day

  11. Constipation Assessment Scale

    This 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.

    Measured: eighteenth day

  12. Constipation Assessment Scale

    This 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.

    Measured: twenty-first day

  13. Constipation Assessment Scale

    This 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.

    Measured: twenty-fourth day

  14. Constipation Assessment Scale

    This 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.

    Measured: twenty-seventh day

  15. Constipation Assessment Scale

    This 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.

    Measured: thirtieth day

  16. Overall Comfort Scale

    It 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.

    Measured: Baseline

  17. Overall Comfort Scale

    It 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.

    Measured: thirty-fifth day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2026
  2. Study start10 Jan 2024
  3. Primary completion30 Nov 2024
  4. Study completion30 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07339293
Sponsor's protocol ID
Constipation Insoles
Status last verified
Jan 2026
First submitted
4 Jan 2026
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Patients have not given permission to share their data in this area.

Publications

  • References Akyüz Özdemir, F., Can, G. 2024. "The Effect of Reflexology Socks in the Management of Opioid-Induced Constipation: A Randomized Controlled Trial", Cancer Nursing, 10-1097. Anjoman, A. Z., Mirghafourvand, M., Hughes, C., Havizari, S. 2021. "Effect of Foot Reflexology on Constipation: A Systematic Review and Meta-Analysis", [Dergi adı belirtilmemiş]. Arıkan Dirimen, G. 2016. "Palyatif Bakım Tanımı ve Felsefesi", Klinik Tıp Aile Hekimliği, 8(3), 1-5. Ayık Bıçak, D., Can, G. 2020. "Palyatif Bakım Hastalarında Konstipasyonun Yönetimi ve Akupresürün Etkinliği", Sağlık Akademisyenleri Dergisi, 7(2), 141-148. Barichella, M. et al. 2016. "Probiotics and Prebiotic Fiber for Constipation Associated with Parkinson Disease", Neurology, 87(12), 1274-1280. Bassotti, G., Battaglia, E. 2023. "Considerations for laxatives in terms of their interactions with other drugs", Expert Opinion on Drug Metabolism & Toxicology, 19(3), 121-123. Bayan, K. 2017. "Konstipasyona Güncel Yaklaşım", Klinik Tıp Bilimleri Dergisi, 5(2). Bharucha, A. E., Lacy, B. E. 2020. "Mechanisms, Evaluation, and Management of Chronic Constipation", Gastroenterology, 158(5), 1232-1249.e3. Camilleri, M. et al. 2017. "Chronic Constipation", Nature Reviews Disease Primers, 3, 1-19. Canbulat Şahiner, N., Demirgoz Bal, M. 2017. "A Randomized Controlled Trial Examining the Effects of Reflexology on Children With Functional Constipation", Gastroenterology Nursing, 40(5), 393-400. Candy, B. et al. 2015. "Laxatives for the Management of Constipation in People Receiving Palliative Care", Cochrane Database of Systematic Reviews, 5. Cevik, K. 2013. "Complementary and Alternative Therapy in Nursing: Reflexology", Ege Hemşirelik Fakültesi Dergisi, 29(2), 71-82. Cevik, K., Zaybak, A. 2018. "The Effect of Reflexology on Constipation in the Elderly", International Journal of Caring Science, 11(1), 309-318. Clark, K., Currow, D. C. 2013. "Constipation in Palliative Care: What Do We Use as Definitions and Outco

Questions about this trial

What is this clinical trial studying?

A study testing constipation insole and Walk in people with Palliative Care and Constipation, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Constipation Severity Scale (time frame: First week). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07339293, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.

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