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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).

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

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.

Turkey (Türkiye)1 site
  • Gürkan

    Malatya, 44090

Other trials in Turkey (Türkiye)

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.

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 groups in NCT04828356
Study groupRoleWhat they receive
Foot reflexology groupExperimentalThe 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 groupNo interventionThe 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.

  1. 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

  2. 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

  3. 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.

  1. First posted2 Apr 2021
  2. Study start26 Dec 2018
  3. Primary completion15 Apr 2020
  4. Study completion16 Jul 2020

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
Model description
Randomized controlled trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (actual)
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

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.

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