The Effect of Exercises on Pain and Kinesiophobia in Transplant Patients

Sponsor

Gurkan KAPIKIRAN (Other)

Overall Status

Completed

CT.gov ID

NCT06085599

Collaborator

(none)

116

Enrollment

Location

Arms

Actual Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Liver transplantation is a treatment method used in acute and chronic liver failure. Progressive Relaxation Exercises, which are non-pharmacological methods aimed at minimizing complications and improving the quality of life after liver transplantation, have been reported to have many benefits such as reducing acute and chronic pain, reducing fatigue and reducing muscle tension. Therefore, in this study, the effects of progressive relaxation exercises on pain and kinesiophobia in liver transplant patients were examined.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplantation	Behavioral: Progressive relaxation exercises	N/A

Detailed Description

Liver transplantation is a common treatment for acute and chronic liver failure, liver malignancy and complicated cirrhosis. Although life expectancy increases after liver transplantation, some undesirable problems such as rejection, cardiovascular risk factors, hypertension, infection and malignancy occur. Preferring non-pharmacological methods to minimise complications and improve quality of life accelerates the return of the individual to normal life. Progressive Relaxation Exercises, one of these methods, can activate the parasympathetic nervous system, blood pressure, heart and respiratory rate can be kept within clinically normal limits due to vasodilatation in the blood vessels in the peripheral area and oxygen requirement is reduced. PGE has been reported to have many benefits such as reducing the effects of anxiety and stress, reducing acute and chronic pain, nausea and vomiting, facilitating sleep, reducing fatigue, reducing respiration, blood pressure, heart rate and muscle tension. Therefore, in this study, the effects of progressive relaxation exercises on pain and kinesiophobia in liver transplant patients were examined.

Study Design

Study Type:

Interventional

Actual Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study was conducted as a randomised controlled study with experimental and control groups.This study was conducted as a randomised controlled study with experimental and control groups.

Masking:

Double (Participant, Investigator)

Masking Description:

Participants did not know which group they were in.

Primary Purpose:

Supportive Care

Official Title:

The Effect of Progressive Relaxation Exercises on Pain and Kinesiophobia After Liver Transplantation

Actual Study Start Date :

Mar 30, 2022

Actual Primary Completion Date :

Mar 30, 2023

Actual Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Progressive relaxation exercise group Sociodemographic information form, numerical pain scale and kinesiophobia scale were applied to the patients in the experimental group after liver transplantation. They were shown 15 minutes progressive relaxation exercises prepared by Mark Connelly and Jennifer Bickel on Youtube, and then the numerical pain scale and kinesiophobia scale were applied again.	Behavioral: Progressive relaxation exercises The progressive muscle relaxation technique involves suggestive stretching and relaxation in sixteen different muscle groups of the body. This technique is based on tensing each muscle group for approximately 10 seconds and then abruptly releasing this tension.
No Intervention: Control group No application other than clinical protocols was performed in the follow-up of the patient. In the control group, sociodemographic information form, kinesiophobia scale and numerical pain scale were applied after liver transplantation. No intervention was made. Then, the kinesiophobia scale and numerical pain scale were applied again.

Arm

Intervention/Treatment

Experimental: Progressive relaxation exercise group

Sociodemographic information form, numerical pain scale and kinesiophobia scale were applied to the patients in the experimental group after liver transplantation. They were shown 15 minutes progressive relaxation exercises prepared by Mark Connelly and Jennifer Bickel on Youtube, and then the numerical pain scale and kinesiophobia scale were applied again.

Behavioral: Progressive relaxation exercises

The progressive muscle relaxation technique involves suggestive stretching and relaxation in sixteen different muscle groups of the body. This technique is based on tensing each muscle group for approximately 10 seconds and then abruptly releasing this tension.

No Intervention: Control group

No application other than clinical protocols was performed in the follow-up of the patient. In the control group, sociodemographic information form, kinesiophobia scale and numerical pain scale were applied after liver transplantation. No intervention was made. Then, the kinesiophobia scale and numerical pain scale were applied again.

Outcome Measures

Primary Outcome Measures

Pain Level [up to 24 hours liver transplant (0-1 day]
The pain levels of the patients were measured by means of the visual pain scale. [Time Frame: up to 24 hours post-surgery (0-1 day)]
Tampa Kinesiophobia Scale (TKS) [up to 24 hours liver transplant (0-1 day]
The kinesiophobia levels of the patients were evaluated postoperatively and 24 hours after surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients over the age of 18 who agreed to participate in the study,
Patients undergoing Liver Transplantation
Patients without a disabling psychiatric disorder

Exclusion Criteria:

Patients under the age of 18 who do not agree to participate in the study.
Those who have a psychiatric diagnosis that prevents communication.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	İnonu Üniversitesi Turgut Özal tıp Merkezi Karaciğer Nakil Enstitüsü	Malatya		Turkey	44090

Sponsors and Collaborators

Gurkan KAPIKIRAN

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gurkan KAPIKIRAN, Assistant Professor, Malatya Turgut Ozal University

ClinicalTrials.gov Identifier:

NCT06085599

Other Study ID Numbers:

2021-07/21-KAEK-109

First Posted:

Oct 17, 2023

Last Update Posted:

Oct 19, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gurkan KAPIKIRAN, Assistant Professor, Malatya Turgut Ozal University

Liver Transplantation

Progressive Relaxation Exercises

Pain

Pain level

Kinesiophobia

Additional relevant MeSH terms:

Kinesiophobia

Study Results

No Results Posted as of Oct 19, 2023