NCT06085599

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 10, 2023

Last Update Submit

October 17, 2023

Conditions

Keywords

Liver TransplantationProgressive Relaxation ExercisesPainPain levelKinesiophobia

Outcome Measures

Primary Outcomes (2)

  • Pain Level

    The pain levels of the patients were measured by means of the visual pain scale. \[Time Frame: up to 24 hours post-surgery (0-1 day)\]

    up to 24 hours liver transplant (0-1 day

  • Tampa Kinesiophobia Scale (TKS)

    The kinesiophobia levels of the patients were evaluated postoperatively and 24 hours after surgery.

    up to 24 hours liver transplant (0-1 day

Study Arms (2)

Progressive relaxation exercise group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

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.

Progressive relaxation exercise group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İnonu Üniversitesi Turgut Özal tıp Merkezi Karaciğer Nakil Enstitüsü

Malatya, 44090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainKinesiophobia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants did not know which group they were in.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was conducted as a randomised controlled study with experimental and control groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 17, 2023

Study Start

March 30, 2022

Primary Completion

March 30, 2023

Study Completion

June 30, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations