Liver Transplant; ComplicationsNCT04828356
The Effect of Foot Reflexology on Pain, Comfort and Beta Endorphin Levels in Patients With Liver Transplantation
A study testing Reflexology in people with Liver Transplant; Complications, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Reflexology application is an effective method in pain control by stimulating the release of endorphins. The Research was carried out to determine the effect of foot reflexology applied to patients with liver transplantation on pain, comfort and beta endorphin levels.The research was carried out as a randomized… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Transplant; Complications
- What is being tested?
- Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Dec 2018to 16 Jul 2020
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- Ability to communicate verbally and not having a cognitive problem
- Defining pain severity of 4 and above
- Willing to participate in the study.
Who cannot join
- The absence of open wounds and cellulite in the area to be applied
- The absence of thrombophlebitis, deep vein thrombosis, inflammatory diseases
- Psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assistant Professor
Reflexology application is an effective method in pain control by stimulating the release of endorphins. The Research was carried out to determine the effect of foot reflexology applied to patients with liver transplantation on pain, comfort and beta endorphin levels.The research was carried out as a randomized controlled study. The population of the study was made up of adult patients who underwent liver transplantation a Liver Transplant Institute in Turkey. The sample consisted of 120 patients with specified power analysis, including analysis 60 experimental and 60 controls. Data were collected between October 2019-April 2020 using Patient Information Form, Numerical Pain Scale, Perianesthesia Comfort Scale and Beta Endorphin Level Registration Form.
Read the detailed description
This study was conducted in an randomized control trial, pre-test/post-test control group design. The study was conducted in an organ transplantation clinic of the Liver Transplantation Institute (LTI) in Turkey between December 2018 and July 2020. Approximately 225 liver transplantations are performed in the LTI in a year.
The population of the study included 147 patients who received liver transplantations in the LTI. The sample size was determined with the G Power 3.1.9.7 program. According to the performed power analysis measurement with 0.7 effect size, 0.05 margin of error, 0.95 confidence interval and 95% power to represent the universe, it was determined that 120 patients (60 in the experimental group, 60 in the control group) should be included in the study. The research protocol was designed according to the CONSORT (Consolidated Standards of Reporting Trials Statement) guidelines. The sample included the patients who met the inclusion criteria and who were selected from the population with the improbable random sampling method. 16 patients who did not meet the inclusion criteria and 11 patients who did not agree to participate in the study were excluded from the study.
Numbers from 1 to 120 were randomly divided into two blocks according to the algorithm created by the computer program. The blocks for the experimental and control groups were determined by lottery method. The first block was determined to be the control group while the second block was determined to be the experimental group.
Inclusion criteria were being: (i) 18 years of age or older, (ii) ability to communicate verbally and not having a cognitive problem, (iii) defining pain severity of 4 and above, and (iv) willing to participate in the study. The exclusion criteria were having: (i) the absence of open wounds and cellulite in the area to be applied, (ii) the absence of thrombophlebitis, deep vein thrombosis, inflammatory diseases, etc., and (iii) psychiatric illness.
Experimental Group The first researcher received hands-on training about reflexology application before the study started. The researcher applied foot reflexology on the patients with liver transplantation in the experimental group in one session (30 minutes) after the operation. Patient confidentiality was maintained in all procedures. It was ensured that the environment was as quiet and calm as possible for the concentration of the researcher and the patient during the application. Television and monitor sounds were reduced and phone tones were muted and turned to silent mode. The patient was asked to lie down in supine position and the researcher prepared the patient for reflexology by supporting their feet with a pillow. After completing all preparations and washing her/his hands, the researcher took some petroleum jelly and rubbed her/his hands and brought it to body temperature. The patient identity form was implemented before reflexology application. Pain and comfort levels were assessed as the pre-test. Then, venous blood was taken to determine the plasma β-End level. Foot reflexology was first applied on the right foot, which is effective on the sympathetic nervous system, for 15 min and then, on the left foot, which is effective on the parasympathetic nervous system, for 15 min. Foot warm-up movements, which are the first step of foot reflexology, were applied on the right foot for 2 min. Then, the warm-up movements were ended by applying deep and painless pressure on the solar plexus area of the foot, on which reflexology was applied, for 1 min. Then, reflexology was applied on brain (epiphysis area on the the thumb, hypothalamus, pituitary points), liver, thyroid, small and large bowels, knee, hip, elbow and shoulder areas and lymphatic system areas. Relaxation movements were then performed, and the session on the right foot session was completed within 15 minutes with the application of pressure on the solar plexus. Same process was performed on the left foot and the reflexology application was completed within 15 min. Venous blood was taken again to assess the β-End level as the post-test after the application, and the NPS and PCQ were implemented again.
Control (No treatment) Group The patient identity form, NPS and PCQ were applied on the patients in the control group as the pre-test. After the questions were answered, venous blood was taken to determine the plasma β-End level. No intervention other than clinical protocol was applied on the control group, and after taking venous blood after 30 minutes to determine β-End level, the NPS and PCQ were re-applied as the post-test.
Laboratory Analyses Venous blood was taken from the patients on the 0 and 30 minutes to measure the β-End level. 5 mL venous blood sample taken from each patient with a sterile single-use 10 cc injector was poured into gold BD Hemogard capped tubes. Blood samples were kept upright at room temperature for 15-20 minutes, then they were centrifuged at +4 ° C, 2000-3000 gauge for 20 minutes. Following the centrifugation, the separated serum was taken from the tubes and stored in Eppendorf tubes at -80 ° C. After completing taking blood samples, serums were thawed and studied in accordance with the kit package insert (Catalog No: YL191012375, YL191012376, YL191012377) to determine β-End level. The laboratory analyses were performed by experts in the Microbiology Department Laboratory of a university.
- Conditions
- Liver Transplant; Complications
- Being tested
- Reflexology
- Keywords
- Liver Transplantation, Foot Reflexology, Pain, Comfort, Beta Endorphin
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyOther
Reflexology application is an energy balancing system with its own pressure technique that provides recovery by rubbing the reflex (nerve endings) points, stroking and applying pressure during squeezing movements. Thanks to the pressure and massage applied to the reflex points, the energy blockages are broken and this energy flow is distributed in a balanced way to the relevant organs.
| Study group | Role | What they receive |
|---|---|---|
| Foot reflexology group | Experimental | The first researcher received hands-on training about reflexology application before the study started. The researcher applied foot reflexology on the patients with liver transplantation in the experimental group in one session (30 minutes) after the operation. Patient confidentiality was maintained in all procedures. The patient identity form was implemented before reflexology application. Pain and comfort levels were assessed as the pre-test. Then, venous blood was taken to determine the plasma β-End level. Foot reflexology was first applied on the right foot, which is effective on the sympathetic nervous system, for 15 min and then, on the left foot, which is effective on the parasympathetic nervous system, for 15 min. Same process was performed on the left foot and the reflexology application was completed within 15 min. Venous blood was taken again to assess the β-End level as the post-test after the application, and the NPS and PCQ were implemented again. Receives: Other: Reflexology |
| No treatment group | No intervention | The patient identity form, NPS and PCQ were applied on the patients in the control group as the pre-test. After the questions were answered, venous blood was taken to determine the plasma β-End level. No intervention other than clinical protocol was applied on the control group, and after taking venous blood after 30 minutes to determine β-End level, the NPS and PCQ were re-applied as the post-test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Scale
It is a numeric scale which is based on explaining pain severity with numbers, and where 0 point means no pain and 10 points mean unbearable pain
Measured: 0.-30. minutes
Beta-Endorphin Level Entry Form
This form, in which the β-End level determined after laboratory analysis is recorded, was established by the researcher.
Measured: 0.-30. minutes
Perianesthesia Comfort Questionnaire (PCQ)
PCQ was established based on the taxonomic structure which forms the hypothetical components of the comfort hypothesis
Measured: 0.-30. minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start26 Dec 2018
- Primary completion15 Apr 2020
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe 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
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurkan Kapikiran, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828356
- Sponsor's protocol ID
- 2018/183
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Professor
- ClinicalTrials.gov ID
- NCT04828356
- Acronym / sponsor ID
- 2018/183
- Conditions
- Liver Transplant; Complications
- Keywords
- Liver Transplantation, Foot Reflexology, Pain, Comfort, Beta Endorphin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 26 Dec 2018 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 2 Apr 2021 (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.
Reflexology application is an effective method in pain control by stimulating the release of endorphins. The Research was carried out to determine the effect of foot reflexology applied to patients with liver transplantation on pain, comfort and beta endorphin levels.The research was carried out as a randomized controlled study. The population of the study was made up of adult patients who underwent liver transplantation a Liver Transplant Institute in Turkey. The sample consisted of 120 patients with specified power analysis, including analysis 60 experimental and 60 controls. Data were collected between October 2019-April 2020 using Patient Information Form, Numerical Pain Scale, Perianesthesia Comfort Scale and Beta Endorphin Level Registration Form.
Detailed description
This study was conducted in an randomized control trial, pre-test/post-test control group design. The study was conducted in an organ transplantation clinic of the Liver Transplantation Institute (LTI) in Turkey between December 2018 and July 2020. Approximately 225 liver transplantations are performed in the LTI in a year.
The population of the study included 147 patients who received liver transplantations in the LTI. The sample size was determined with the G Power 3.1.9.7 program. According to the performed power analysis measurement with 0.7 effect size, 0.05 margin of error, 0.95 confidence interval and 95% power to represent the universe, it was determined that 120 patients (60 in the experimental group, 60 in the control group) should be included in the study. The research protocol was designed according to the CONSORT (Consolidated Standards of Reporting Trials Statement) guidelines. The sample included the patients who met the inclusion criteria and who were selected from the population with the improbable random sampling method. 16 patients who did not meet the inclusion criteria and 11 patients who did not agree to participate in the study were excluded from the study.
Numbers from 1 to 120 were randomly divided into two blocks according to the algorithm created by the computer program. The blocks for the experimental and control groups were determined by lottery method. The first block was determined to be the control group while the second block was determined to be the experimental group.
Inclusion criteria were being: (i) 18 years of age or older, (ii) ability to communicate verbally and not having a cognitive problem, (iii) defining pain severity of 4 and above, and (iv) willing to participate in the study. The exclusion criteria were having: (i) the absence of open wounds and cellulite in the area to be applied, (ii) the absence of thrombophlebitis, deep vein thrombosis, inflammatory diseases, etc., and (iii) psychiatric illness.
Experimental Group The first researcher received hands-on training about reflexology application before the study started. The researcher applied foot reflexology on the patients with liver transplantation in the experimental group in one session (30 minutes) after the operation. Patient confidentiality was maintained in all procedures. It was ensured that the environment was as quiet and calm as possible for the concentration of the researcher and the patient during the application. Television and monitor sounds were reduced and phone tones were muted and turned to silent mode. The patient was asked to lie down in supine position and the researcher prepared the patient for reflexology by supporting their feet with a pillow. After completing all preparations and washing her/his hands, the researcher took some petroleum jelly and rubbed her/his hands and brought it to body temperature. The patient identity form was implemented before reflexology application. Pain and comfort levels were assessed as the pre-test. Then, venous blood was taken to determine the plasma β-End level. Foot reflexology was first applied on the right foot, which is effective on the sympathetic nervous system, for 15 min and then, on the left foot, which is effective on the parasympathetic nervous system, for 15 min. Foot warm-up movements, which are the first step of foot reflexology, were applied on the right foot for 2 min. Then, the warm-up movements were ended by applying deep and painless pressure on the solar plexus area of the foot, on which reflexology was applied, for 1 min. Then, reflexology was applied on brain (epiphysis area on the the thumb, hypothalamus, pituitary points), liver, thyroid, small and large bowels, knee, hip, elbow and shoulder areas and lymphatic system areas. Relaxation movements were then performed, and the session on the right foot session was completed within 15 minutes with the application of pressure on the solar plexus. Same process was performed on the left foot and the reflexology application was completed within 15 min. Venous blood was taken again to assess the β-End level as the post-test after the application, and the NPS and PCQ were implemented again.
Control (No treatment) Group The patient identity form, NPS and PCQ were applied on the patients in the control group as the pre-test. After the questions were answered, venous blood was taken to determine the plasma β-End level. No intervention other than clinical protocol was applied on the control group, and after taking venous blood after 30 minutes to determine β-End level, the NPS and PCQ were re-applied as the post-test.
Laboratory Analyses Venous blood was taken from the patients on the 0 and 30 minutes to measure the β-End level. 5 mL venous blood sample taken from each patient with a sterile single-use 10 cc injector was poured into gold BD Hemogard capped tubes. Blood samples were kept upright at room temperature for 15-20 minutes, then they were centrifuged at +4 ° C, 2000-3000 gauge for 20 minutes. Following the centrifugation, the separated serum was taken from the tubes and stored in Eppendorf tubes at -80 ° C. After completing taking blood samples, serums were thawed and studied in accordance with the kit package insert (Catalog No: YL191012375, YL191012376, YL191012377) to determine β-End level. The laboratory analyses were performed by experts in the Microbiology Department Laboratory of a university.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Foot reflexology group | Experimental | Other: ReflexologyThe first researcher received hands-on training about reflexology application before the study started. The researcher applied foot reflexology on the patients with liver transplantation in the experimental group in one session (30 minutes) after the operation. Patient confidentiality was maintained in all procedures. The patient identity form was implemented before reflexology application. Pain and comfort levels were assessed as the pre-test. Then, venous blood was taken to determine the plasma β-End level. Foot reflexology was first applied on the right foot, which is effective on the sympathetic nervous system, for 15 min and then, on the left foot, which is effective on the parasympathetic nervous system, for 15 min. Same process was performed on the left foot and the reflexology application was completed within 15 min. Venous blood was taken again to assess the β-End level as the post-test after the application, and the NPS and PCQ were implemented again. |
| No treatment group | No intervention | –The patient identity form, NPS and PCQ were applied on the patients in the control group as the pre-test. After the questions were answered, venous blood was taken to determine the plasma β-End level. No intervention other than clinical protocol was applied on the control group, and after taking venous blood after 30 minutes to determine β-End level, the NPS and PCQ were re-applied as the post-test. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older,
- Ability to communicate verbally and not having a cognitive problem
- Defining pain severity of 4 and above
- Willing to participate in the study.
Key exclusion criteria (3 listed)
- The absence of open wounds and cellulite in the area to be applied
- The absence of thrombophlebitis, deep vein thrombosis, inflammatory diseases
- Psychiatric illness.
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 is an energy balancing system with its own pressure technique that provides recovery by rubbing the reflex (nerve endings) points, stroking and applying pressure during squeezing movements. Thanks to the pressure and massage applied to the reflex points, the energy blockages are broken and this energy flow is distributed in a balanced way to the relevant organs. | Other | Foot reflexology group |
Primary outcome
Numeric Pain Scale
Time frame: 0.-30. minutes
It is a numeric scale which is based on explaining pain severity with numbers, and where 0 point means no pain and 10 points mean unbearable pain
Beta-Endorphin Level Entry Form
Time frame: 0.-30. minutes
This form, in which the β-End level determined after laboratory analysis is recorded, was established by the researcher.
Perianesthesia Comfort Questionnaire (PCQ)
Time frame: 0.-30. minutes
PCQ was established based on the taxonomic structure which forms the hypothetical components of the comfort hypothesis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology in people with Liver Transplant; Complications, run by Inonu 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 4 inclusion and 3 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 3 Nov 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?
Numeric Pain Scale (time frame: 0.-30. minutes). The study lists 3 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 3 Nov 2026.