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

Sponsor
Kırklareli University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06023485
Collaborator
(none)
134
1
2
6
22.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: stress ball use during subcutaneous injection
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
134 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Stress Ball Use on Procedural Pain Caused by Subcutaneous Injection in Orthopedic Patients
Actual Study Start Date :
Mar 1, 2023
Actual Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group (stress ball)

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.

Other: stress ball use during subcutaneous injection
The effect of stress ball use on pain during subcutaneous injection

No Intervention: Control group

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.

Outcome Measures

Primary Outcome Measures

  1. pain management during subcutaneous injection [9 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kırklareli University Kırklareli Turkey 39100

Sponsors and Collaborators

  • Kırklareli University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Figen Dıgın, Assistant Professor, Kırklareli University
ClinicalTrials.gov Identifier:
NCT06023485
Other Study ID Numbers:
  • The Effect of Stress Ball Use
  • KLÜBAP-249
  • 2023-249
  • 2023-249
First Posted:
Sep 5, 2023
Last Update Posted:
Sep 7, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 7, 2023