The Effect of Foot Reflexology on Pain, Comfort and Beta Endorphin Levels in Patients With Liver Transplantation

NCT04828356 | Completed DMC

• 1 other identifier: 2018/183
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Liver Transplant; Complications

Keywords

Liver Transplantation; Foot Reflexology; Pain; Comfort; Beta Endorphin

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  0.-30. minutes

• Perianesthesia Comfort Questionnaire (PCQ)

  PCQ was established based on the taxonomic structure which forms the hypothetical components of the comfort hypothesis

  0.-30. minutes

Study Arms (2)

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.

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.

Interventions

Reflexology OTHER

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.

Foot reflexology group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The absence of open wounds and cellulite in the area to be applied
• The absence of thrombophlebitis, deep vein thrombosis, inflammatory diseases
• Psychiatric illness.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Gürkan

Malatya, 44090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 2, 2021
• Study Start: December 26, 2018
• Primary Completion: April 15, 2020
• Study Completion: July 16, 2020
• Last Updated: April 2, 2021

Record last verified: 2021-03

Locations

TU (1)