NCT05887596

Brief Summary

Objective: The study was conducted to determine the effect of patient education on pain level and fear of pain in orthopedics and traumatology patients Methods: The study is a randomized controlled experimental research design. Data were collected between December 15, 2021, and March 15, 2022 using the Information Form, Fear of Pain Scale-III, and Visual/Visual Analogue Scale. A total of 52 patients, 26 in the intervention group and 26 in the control group were included in the study. The intervention group received patient education about the operation process and pain management the day before and the morning of the operation day. Number Cruncher Statistical System and Statistical Software (Kaysville, Utah, USA) were used to analyse the data Keywords: Fear of Pain, Pain, Pain Management, Patient Education

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

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

December 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

May 10, 2023

Last Update Submit

May 24, 2023

Conditions

Keywords

Fear of PainPainPain ManagementPatient Education

Outcome Measures

Primary Outcomes (1)

  • Pain Level

    The primary point of the study was defined was assessed by a Visual/Visual Analogue Scale the effect of patient education on pain level in orthopedics and traumatology patients.

    3 months

Secondary Outcomes (1)

  • Fear of Pain

    3 months

Study Arms (2)

Control group

NO INTERVENTION

The training given to the control group included preoperative preparation, operating theatre environment, breathing exercises, cough exercises, etc. to be performed after surgery. In both groups, temperature, pulse rate, blood pressure, oxygen saturation level, and pain level with a Visual/Visual Analogue Scale were measured on the morning of the operation day, before the operation, every 4 hours for 24 hours after the operation and on the day of discharge. Again, pain fear level was measured with the Fear of Pain Scale-III on the day of discharge in both groups.

Intervention group

EXPERIMENTAL

The education given to the intervention group included preoperative preparation, operating room environment, breathing exercises, cough exercises, etc. to be performed after surgery, non-pharmacological methods related to pain management (cold application, positioning, distraction), and pharmacological methods related to pain management.

Other: Patient education

Interventions

The education given to the intervention group included preoperative preparation, operating room environment, breathing exercises, cough exercises, etc. to be performed after surgery, non-pharmacological methods related to pain management (cold application, positioning, distraction), and pharmacological methods related to pain management.

Also known as: Patients receiving patient education on pain management
Intervention group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • open to communication and cooperation,
  • had no cognitive and mental problems,
  • volunteered to participate in the study

You may not qualify if:

  • closed to communication and cooperation,
  • had cognitive and mental problems,
  • not volunteered to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Bakırköy, 34140, Turkey (Türkiye)

Location

Related Publications (1)

  • Caliskan F, Seller A, Gercek M. The Effect of Patient Education on Pain Level and Fear of Pain in Orthopedic Surgery: A Randomized Controlled Trial. J Perianesth Nurs. 2025 Jun;40(3):612-618. doi: 10.1016/j.jopan.2024.07.015. Epub 2024 Oct 24.

MeSH Terms

Conditions

PainAgnosia

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Figen Çalışkan, Assoc. prof

    Trakya University, Turkey

    PRINCIPAL INVESTIGATOR
  • Ayten Seller, Nurse

    Bakırköy Dr. Sadi Konuk Training and Research Hospital, Turkey

    PRINCIPAL INVESTIGATOR
  • Muhterem Gerçek, Nurse

    Bakırköy Dr. Sadi Konuk Training and Research Hospital, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof.

Study Record Dates

First Submitted

May 10, 2023

First Posted

June 2, 2023

Study Start

December 15, 2021

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

June 2, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations