NCT05950217

Brief Summary

Providing information to the patient before surgery has important effects on the patient's self-care skills regarding the treatment and care process, reducing stress and reducing fears in the postoperative period. The primary aim of this study was to examine the effect of preoperative education on kinesiophobia in patients undergoing total knee replacement surgery. In addition, preoperative anxiety levels, time of first postoperative mobilization, number of steps in the first 24 hours after mobilization and pain levels of the patients will be evaluated as secondary outcomes.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

July 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2024

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

July 10, 2023

Last Update Submit

July 17, 2023

Conditions

Kinesiophobia

Keywords

KinesiophobiaKnee replacementNursing educationPreoperative care

Outcome Measures

Primary Outcomes (1)

  • Kinesiophobia

    Self reported kinesiophobia intensity after surgical process that includes one day after surgery. TAMPA Kinesiophobia Scale (TSK) will be used to evaluate the kinesiophobia. The TSK consists of 17 items that are rated on a 4-point Likert scale, ranging from "Strongly Disagree" to "Strongly Agree." It is scored by assigning a numerical value to each response. Individual item scores range from 1-4, with the negatively worded items (4,8,12,16) having a reverse scoring (4-1). The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.

    2 days

Secondary Outcomes (4)

  • Anxiety level

    2 days

  • Pain level

    1 day

  • First postoperative mobilization time

    1 day

  • Number of steps in the first 24 hours after mobilization

    1 day

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group patients will be educated by the nurse in the preoperative period with the support of visual education material

Other: Education

Control Group

NO INTERVENTION

The control group will take rutin patient care.

Interventions

EducationOTHER

Nurse-led patient education

Experimental Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age or older
  • Planned surgery
  • Speaking and understanding Turkish
  • Being admitted to the hospital at least one day before the surgery

You may not qualify if:

  • Visual, hearing and speech disabilities,
  • Being mentally disabled,
  • Having a psychiatric disorder or being in the process of treatment
  • Having had knee replacement surgery before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bahar Candas Altinbas

Trabzon, 61800, Turkey (Türkiye)

Location

Nurdan Reis

Trabzon, 61800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kinesiophobia

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Bahar Candas Altinbas, PhD

    Karadeniz Technical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bahar Candas Altinbas, PhD

CONTACT

+90 545 9125343baharcandas88@gmail.com

Nurdan Reis

CONTACT

+90 546 7832632nurdangungoreis@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 18, 2023

Study Start

August 1, 2023

Primary Completion

December 29, 2023

Study Completion

May 29, 2024

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)