NCT05295199

Brief Summary

This study was planned to determine the effect of progressive relaxation exercise to be applied after major orthopedic surgery on post-operative fatigue and comfort level.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 10, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

March 10, 2022

Last Update Submit

July 21, 2022

Conditions

Orthopedic Surgery

Outcome Measures

Primary Outcomes (2)

  • General Comfort Scale

    It is a scale developed to determine the comfort levels of patients.The lowest possible score is 48, the median score is 120, and the highest score is 192. As the score obtained from the scale increases, the level of comfort perceived by the patient increases.

    1st day after surgery

  • Postoperative Fatigue Scale

    It is a scale created to evaluate the post-operative fatigue level of patients.

    1st day after surgery

Secondary Outcomes (2)

  • General Comfort Scale

    4th day after surgery

  • Postoperative Fatigue Scale

    4th day after surgery

Study Arms (2)

Experimental

EXPERIMENTAL

Routine maintenance and Progressive relaxation exercise

Other: Progressive relaxation exercise

Control

NO INTERVENTION

Routine maintenance

Interventions

Progressive relaxation exerciseOTHER

Progressive relaxation exercise is a type of exercise that involves voluntary stretching and relaxation of major muscle groups in the human body, from the hands to the feet.

Experimental

Eligibility Criteria

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

You may qualify if:

  • The patients included in the study have undergone major orthopedic surgery (total knee or hip replacement, atroscopic surgery, vertebral surgery, shoulder surgery, amputation, etc.), Patients aged 18 and over Absence of speech and hearing problems Speak and understand Turkish

You may not qualify if:

  • Being diagnosed with a psychiatric disorder, A complication developed in the patients before, during and three days after the operation,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aksaray University

Aksaray, 68100, Turkey (Türkiye)

RECRUITING

Study Officials

  • Funda CETINKAYA

    Aksaray University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 25, 2022

Study Start

March 10, 2022

Primary Completion

August 30, 2022

Study Completion

August 30, 2022

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)