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The Effect of Stress Ball Use on Procedural Pain Caused by Subcutaneous Injection in Orthopedic Patients

Primary Purpose

Misadventure During Injection / Vaccination

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
stress ball use during subcutaneous injection
Sponsored by
Kırklareli University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Misadventure During Injection / Vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: patients; who were hospitalized in the orthopedics and traumatology clinic, who were in the post-operative period, who were not diabetic, who were conscious, who were cooperative and oriented (without delirium, etc.), who were not diagnosed with psychiatric disease, who could localize pain, who did not undergo upper extremity surgery, and who volunteered to participate in the study. Exclusion Criteria: Patients who do not volunteer to participate in the study will not be included.

Sites / Locations

  • Kırklareli UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group (stress ball)

Control group

Arm Description

The patients in the experimental group will be given a stress ball before the SC injection during the routine daytime treatment of the ward at 10:00. The patient will be asked to squeeze the stress ball with his hand on the opposite extremity of the upper extremity where SC injection was applied, counting to five, and then to relax his hand. In the meantime, 0.4 ml of LMWH will be administered by SC route according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with VAS.

For the patients in the control group, 0.4 ml of LMWH will be administered by the nurse in the routine daytime treatment of the service at 10:00, according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with VAS.

Outcomes

Primary Outcome Measures

pain management during subcutaneous injection
The patient will be asked to squeeze the stress ball with his hand on the opposite extremity of the upper extremity where SC injection was applied, counting to five, and then to relax his hand. In the meantime, 0.4 ml of LMWH will be administered by SC route according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with Vizuel Analog Scala (VAS). The VAS is a unidimensional scale frequently used to measure pain severity. The scale consists of a 10-cm demarcated line in which 0 cm represents no pain and 10 cm represents unbearable pain.

Secondary Outcome Measures

Full Information

First Posted
August 27, 2023
Last Updated
September 22, 2023
Sponsor
Kırklareli University
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1. Study Identification

Unique Protocol Identification Number
NCT06023485
Brief Title
The Effect of Stress Ball Use on Procedural Pain Caused by Subcutaneous Injection in Orthopedic Patients
Official Title
The Effect of Stress Ball Use on Procedural Pain Caused by Subcutaneous Injection in Orthopedic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırklareli University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Randomization in the study will be done by the researchers with the Randomizer Research program. The research will be carried out between 01.01.2023 and 01.10.2023 with the participation of 134 patients who were hospitalized in the postoperative period at Trakya University Health Research and Application Center Orthopedics and Traumatology Service and participated voluntarily. In the study, in the G.Power 3.1.9.4 program, the effect size was 0.5, the confidence level was 95%, and the power was 80%, and the minimum sample size to be reached was 134 patients (67 experiments- 67 controls), each group consisting of 67 people. Before the study, all patients will be informed by the researchers, and written consent will be obtained from the patients who volunteered to participate in the study. All patients will be asked the questions in the Patient Information Form and the pretest Vizuel Analog Scala (VAS) scores in the Patient follow-up form will be recorded before the subcutaneous (SC) injection application. The patients in the experimental group will be given a stress ball before the SC injection during the routine daytime treatment of the ward at 10:00. The patient will be asked to squeeze the stress ball with his hand on the opposite extremity of the upper extremity where SC injection was applied, counting to five, and then to relax his hand. The level of pain in the area where SC was applied will be evaluated with VAS. For the patients in the control group, 0.4 ml of LMWH will be administered by the nurse in the routine daytime treatment of the service at 10:00, according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with VAS.
Detailed Description
The ramdomized research will be carried out between 01.01.2023 and 01.10.2023 with the participation of 134 patients who were hospitalized in the postoperative period at Trakya University Health Research and Application Center Orthopedics and Traumatology Service and participated voluntarily. In the study, in the G.Power 3.1.9.4 program, the effect size was 0.5, the confidence level was 95%, and the power was 80%, and the minimum sample size to be reached was 134 patients (67 experiments- 67 controls), each group consisting of 67 people. The study included 18 patients who were hospitalized in the orthopedics and traumatology clinic, were in the post-operative period, were not diabetic, conscious, cooperative and oriented (without delirium, etc.), without a diagnosis of psychiatric disease, who could localize the pain, did not undergo upper extremity surgery, and volunteered to participate in the study. Age and older patients will be included. Before the study, all patients will be informed by the researchers, and written consent will be obtained from the patients who volunteered to participate in the study. All patients will be asked the questions in the Patient Information Form and the pretest Vizuel Analog Scala (VAS) scores in the Patient follow-up form will be recorded before the subcutaneous (SC) injection application. The patients in the experimental group will be given a stress ball before the SC injection during the routine daytime treatment of the ward at 10:00. The patient will be asked to squeeze the stress ball with his hand on the opposite extremity of the upper extremity where SC injection was applied, counting to five, and then to relax his hand. In the meantime, 0.4 ml of LMWH will be administered by SC route according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with VAS. For the patients in the control group, 0.4 ml of LMWH will be administered by the nurse in the routine daytime treatment of the service at 10:00, according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with VAS. Unlike the control group, the patients in the experimental group will be asked to tighten and loosen the stress ball during SC injection

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Misadventure During Injection / Vaccination

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group (stress ball)
Arm Type
Experimental
Arm Description
The patients in the experimental group will be given a stress ball before the SC injection during the routine daytime treatment of the ward at 10:00. The patient will be asked to squeeze the stress ball with his hand on the opposite extremity of the upper extremity where SC injection was applied, counting to five, and then to relax his hand. In the meantime, 0.4 ml of LMWH will be administered by SC route according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with VAS.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
For the patients in the control group, 0.4 ml of LMWH will be administered by the nurse in the routine daytime treatment of the service at 10:00, according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with VAS.
Intervention Type
Other
Intervention Name(s)
stress ball use during subcutaneous injection
Intervention Description
The effect of stress ball use on pain during subcutaneous injection
Primary Outcome Measure Information:
Title
pain management during subcutaneous injection
Description
The patient will be asked to squeeze the stress ball with his hand on the opposite extremity of the upper extremity where SC injection was applied, counting to five, and then to relax his hand. In the meantime, 0.4 ml of LMWH will be administered by SC route according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with Vizuel Analog Scala (VAS). The VAS is a unidimensional scale frequently used to measure pain severity. The scale consists of a 10-cm demarcated line in which 0 cm represents no pain and 10 cm represents unbearable pain.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients; who were hospitalized in the orthopedics and traumatology clinic, who were in the post-operative period, who were not diabetic, who were conscious, who were cooperative and oriented (without delirium, etc.), who were not diagnosed with psychiatric disease, who could localize pain, who did not undergo upper extremity surgery, and who volunteered to participate in the study. Exclusion Criteria: Patients who do not volunteer to participate in the study will not be included.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FİGEN DIĞIN, DOCTORATE
Phone
5056461929
Email
fgndgn2013@gmail.com
Facility Information:
Facility Name
Kırklareli University
City
Kırklareli
ZIP/Postal Code
39100
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Stress Ball Use on Procedural Pain Caused by Subcutaneous Injection in Orthopedic Patients

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