Colorectal SurgeryNCT06972199
Reflexology Massage and Hot Water Foot Bath for Pain and GI Recovery After Colorectal Surgery
A study testing Reflexology and Hot water foot bath in people with Colorectal Surgery and Reflexology, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial summary
This study was planned to examine the effect of non-invasive treatment methods that can be applied to alleviate complications involving gastrointestinal system functions such as pain, nausea, vomiting, and absence of gas/faecal output after colorectal (colon and rectum) cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery, Reflexology, Traditional Chinese Medication (TCM)
- What is being tested?
- Reflexology and Hot water foot bath
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Oct 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- Planning laparoscopic surgery for a malignant tumour in the large intestine,
- The same method was used for preoperative bowel and GI tract preparation,
- Postoperative Numerical Proportioning Scale (NRS) score of 3 and above,
- Verbal and written acceptance to participate in the research.
Who cannot join
- The patient has a temporary or permanent stoma,
- Having a history of reflexology application before,
- Open wound, infection, circulatory disorder, lesion, etc. in the areas where reflexology massage or hot water foot bath will be applied,
- Patient-controlled analgesia in the early postoperative period
- Having any problem that prevents verbal communication.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Istanbul University-Cerrahpaşa
Istanbul, Istanbul, 34320
Nuray Akyüz, Assoc Prof, +90532 625 6188, nuray.akyuz@iuc.edu.tr
Mert, Master
- Recruiting
University of Health Sciences, Umraniye Training and Research Hospital
Istanbul, 34764
Cansu Mert, MSc., +90-216-910-1907, cansu.mert@ogr.iuc.edu.tr
Nuray Akyüz, Assoc Prof
About this study
Official title: The Effect of Reflexology Massage and Hot Water Foot Bath on Pain and Gastrointestinal Functions After Colorectal Surgery
This study was planned to examine the effect of non-invasive treatment methods that can be applied to alleviate complications involving gastrointestinal system functions such as pain, nausea, vomiting, and absence of gas/faecal output after colorectal (colon and rectum) cancer surgery. The two main intervention methods of the study were reflexology massage and hot water foot bath. The effects of these methods on reducing postoperative pain and improving gastrointestinal functions will be investigated. The study was planned as a randomised controlled experimental study to determine the effects of reflexology massage and hot water foot bath on postoperative pain and gastrointestinal functions in colorectal cancer patients undergoing laparoscopic surgery. It is thought that the study will provide evidence for determining the appropriate method to reduce pain and improve gastrointestinal functions in patients undergoing colorectal cancer surgery. The population of the study will consist of colorectal cancer patients who will undergo laparoscopic surgical intervention who are admitted to the General Surgery Clinic of SBU Istanbul Ümraniye Training and Research Hospital.
Based on the percentage measurement values of the methods to be studied in the literature review, G-POWER programme was used for sample calculation with an effect size of 0.4 (Cohen), 95% power and 0.05% margin of error. Cohen\'s standard effect size was taken as the basis for the effect size. The calculated value is the total value for 3 groups and the total sample size for 3 groups was found as n=102. The number of samples per group was determined as (n)=34. In order to prevent bias in the study, patients who meet the study criteria will be distributed to the experimental and control groups by computerised randomisation programme. Data will be collected by using the Patient Information Form consisting of two parts, Rhodes Nausea, Vomiting and Retching Index and Numerical Proportioning Scale (NRS) developed by the researcher in line with the literature. The data obtained will be evaluated with appropriate statistical methods in the licensed SPSS 21.0 package programme.
Read the detailed description
This randomized controlled trial aims to evaluate the effectiveness of two non-pharmacological interventions-reflexology massage and hot water foot bath-on postoperative pain and gastrointestinal function in patients undergoing laparoscopic colorectal cancer surgery. The interventions will be applied in three groups: reflexology massage, hot water foot bath, and control group. Participants will be randomly assigned to groups using a computerized randomization method. Pain will be assessed using the Numerical Rating Scale (NRS), and gastrointestinal function will be evaluated through time to first gas and feces passage, as well as bowel sounds. Additionally, the Rhodes Index of Nausea, Vomiting, and Retching (RINVR) will be used to monitor symptoms related to postoperative nausea and vomiting. Data will also be collected using a researcher-developed Data Collection Form consisting of:
- Sociodemographic characteristics
- Medical and surgical history
- Postoperative vital signs (blood pressure, pulse, temperature, etc.)
- Gastrointestinal follow-up (bowel sounds per minute, time of first gas and feces output) This form was developed based on current literature and clinical practice guidelines and piloted prior to study launch. All data will be analyzed using SPSS 21.0.
The sample size was calculated using G*Power based on an effect size of 0.4 (Cohen), 95% power, and a 0.05 margin of error, resulting in 102 total participants (n=34 per group).
Ethical approval was obtained from the Non-Interventional Clinical Research Ethics Committee of Fenerbahçe University. The study is being conducted at the General Surgery Clinic of SBÜ Ümraniye Training and Research Hospital.
- Being tested
- Reflexology, Hot water foot bath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyBehavioural
Reflexology application
Hot water foot bathBehavioural
Hot water foot bath application
| Study group | Role | What they receive |
|---|---|---|
| Reflexology | Experimental | Reflexology application Receives: Behavioral: Reflexology |
| Hot water foot bath | Experimental | Hot water foot bath application Receives: Behavioral: Hot water foot bath |
| Control | No intervention | There will be no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Postoperative pain levels of the participants will be measured with the Numerical Rating Scale (NRS), which ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Measured: Within 24 hours postoperatively
Gas release time
Time to first gas release of participants in the postoperative period after surgery
Measured: Within 24 hours postoperatively
Secondary outcomes (2)
Neusea
In the postoperative period, nausea and vomiting will be evaluated with the Rhodes Nausea, Vomiting and Retching Index (RNVRI), which has a total score range from 0 to 32. Higher scores indicate more severe symptoms.
Measured: Within 24 hours postoperatively
Number of vomiting
The number of vomits occurring in the participants in the postoperative period will be recorded.
Measured: Within 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start30 Oct 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Mert, Istanbul University - Cerrahpasa
- Investigators
- Cansu Mert, Master, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972199
- Sponsor's protocol ID
- 18.2024fbu
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reflexology Massage and Hot Water Foot Bath on Pain and Gastrointestinal Functions After Colorectal Surgery
- ClinicalTrials.gov ID
- NCT06972199
- Acronym / sponsor ID
- 18.2024fbu
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was planned to examine the effect of non-invasive treatment methods that can be applied to alleviate complications involving gastrointestinal system functions such as pain, nausea, vomiting, and absence of gas/faecal output after colorectal (colon and rectum) cancer surgery. The two main intervention methods of the study were reflexology massage and hot water foot bath. The effects of these methods on reducing postoperative pain and improving gastrointestinal functions will be investigated. The study was planned as a randomised controlled experimental study to determine the effects of reflexology massage and hot water foot bath on postoperative pain and gastrointestinal functions in colorectal cancer patients undergoing laparoscopic surgery. It is thought that the study will provide evidence for determining the appropriate method to reduce pain and improve gastrointestinal functions in patients undergoing colorectal cancer surgery. The population of the study will consist of colorectal cancer patients who will undergo laparoscopic surgical intervention who are admitted to the General Surgery Clinic of SBU Istanbul Ümraniye Training and Research Hospital.
Based on the percentage measurement values of the methods to be studied in the literature review, G-POWER programme was used for sample calculation with an effect size of 0.4 (Cohen), 95% power and 0.05% margin of error. Cohen\'s standard effect size was taken as the basis for the effect size. The calculated value is the total value for 3 groups and the total sample size for 3 groups was found as n=102. The number of samples per group was determined as (n)=34. In order to prevent bias in the study, patients who meet the study criteria will be distributed to the experimental and control groups by computerised randomisation programme. Data will be collected by using the Patient Information Form consisting of two parts, Rhodes Nausea, Vomiting and Retching Index and Numerical Proportioning Scale (NRS) developed by the researcher in line with the literature. The data obtained will be evaluated with appropriate statistical methods in the licensed SPSS 21.0 package programme.
Detailed description
This randomized controlled trial aims to evaluate the effectiveness of two non-pharmacological interventions-reflexology massage and hot water foot bath-on postoperative pain and gastrointestinal function in patients undergoing laparoscopic colorectal cancer surgery. The interventions will be applied in three groups: reflexology massage, hot water foot bath, and control group. Participants will be randomly assigned to groups using a computerized randomization method. Pain will be assessed using the Numerical Rating Scale (NRS), and gastrointestinal function will be evaluated through time to first gas and feces passage, as well as bowel sounds. Additionally, the Rhodes Index of Nausea, Vomiting, and Retching (RINVR) will be used to monitor symptoms related to postoperative nausea and vomiting. Data will also be collected using a researcher-developed Data Collection Form consisting of:
- Sociodemographic characteristics
- Medical and surgical history
- Postoperative vital signs (blood pressure, pulse, temperature, etc.)
- Gastrointestinal follow-up (bowel sounds per minute, time of first gas and feces output) This form was developed based on current literature and clinical practice guidelines and piloted prior to study launch. All data will be analyzed using SPSS 21.0.
The sample size was calculated using G*Power based on an effect size of 0.4 (Cohen), 95% power, and a 0.05 margin of error, resulting in 102 total participants (n=34 per group).
Ethical approval was obtained from the Non-Interventional Clinical Research Ethics Committee of Fenerbahçe University. The study is being conducted at the General Surgery Clinic of SBÜ Ümraniye Training and Research Hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reflexology | Experimental | Behavioral: ReflexologyReflexology application |
| Hot water foot bath | Experimental | Behavioral: Hot water foot bathHot water foot bath application |
| Control | No intervention | –There will be no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older,
- Planning laparoscopic surgery for a malignant tumour in the large intestine,
- The same method was used for preoperative bowel and GI tract preparation,
- Postoperative Numerical Proportioning Scale (NRS) score of 3 and above,
- Verbal and written acceptance to participate in the research.
Key exclusion criteria (5 listed)
- The patient has a temporary or permanent stoma,
- Having a history of reflexology application before,
- Open wound, infection, circulatory disorder, lesion, etc. in the areas where reflexology massage or hot water foot bath will be applied,
- Patient-controlled analgesia in the early postoperative period
- Having any problem that prevents verbal communication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReflexologyReflexology application | Behavioural | Reflexology |
| Hot water foot bathHot water foot bath application | Behavioural | Hot water foot bath |
Primary outcome
Pain level
Time frame: Within 24 hours postoperatively
Postoperative pain levels of the participants will be measured with the Numerical Rating Scale (NRS), which ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Gas release time
Time frame: Within 24 hours postoperatively
Time to first gas release of participants in the postoperative period after surgery
2 secondary outcomes
Neusea
Time frame: Within 24 hours postoperatively
Number of vomiting
Time frame: Within 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
Related trials for Colorectal Surgery
Not yet recruiting
Tailored Nutrition vs. Exercise Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingPhase 2
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cansu Mert, Master principal investigator
Istanbul University - Cerrahpasa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology and Hot water foot bath in people with Colorectal Surgery and Reflexology, run by Istanbul University - Cerrahpasa at 2 sites 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 5 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: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cansu Mert, Master (536 595 4172, cannsumert@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: Within 24 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2025.