Effect of Hand Holding on Pain and Anxiety

May 12, 2024 updated by: Serpil SU, Necmettin Erbakan University

Effect of Hand Holding on Reducing Intramuscular Injection-Induced Pain and Anxiety: A Randomized Controlled Study

It was aimed to examine the effect of the hand holding method applied during intramuscular injection on pain and anxiety.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study was designed as a pre-test-post-test regular parallel group, randomized controlled experimental design. The research will be carried out in the Adult Emergency Service of the Ministry of Health of the Republic of Turkey, Konya City Hospital. Patients will be randomly divided into two groups: handholding (52) and control group (52). For the Hand Holding Group: After the patient is positioned appropriately, the patient's hand will be held by the researcher. Once the intramuscular injection is completed, the patient's hand holding will be stopped. For the Control Group: No application will be made during intramuscular injection in the control group. The primary outcome of this study is to determine patients' pain scores during the intramuscular injection procedure. The secondary outcome is to determine the anxiety levels of patients.

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having vitamin B 12 1000 mcg/ml (1 ml ampoule) intramuscular treatment,
  • Being literate,
  • Are between the ages of 18-65,
  • No visual, hearing, sensory or motor loss or cognitive impairment,
  • Not using centrally or peripherally acting analgesics or sedatives,
  • There is no scar tissue, incision, lipodystrophy or signs of infection on the skin of the injection area,
  • Having a body mass index between 18.5 and 29.5,
  • Injected into the ventrogluteal area,
  • Individuals who agree to participate in the research will be included.

Exclusion Criteria:

  • Those with chronic pain,
  • Having a psychiatric disorder,
  • Foreign nationals,
  • Patients with contact-communicable diseases will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hand Holding Group
In the experimental group, hand holding will be done by the researcher, and intramuscular injection will be done by the clinical nurse. All intramuscular injections will be performed by a single nurse and the ventrogluteal region will be used as the injection site. Patients will first fill out the Voluntary Information and Consent Form, and then the Descriptive Characteristics Form and State Anxiety Scale. After the injection site is evaluated, the researcher will hold the patient's hand, the nurse will enter the tissue at a 90-degree angle and administer the drug slowly (1 ml/10 seconds). After removing the needle from the tissue, the nurse will apply pressure with dry cotton, and then the researcher will stop holding the patient's hand. After the procedure, the Numerical Pain Scale and State Anxiety Scale will be filled in within 1 minute.
Other: Hand Holding
During the intramuscular injection, the aim is to draw the patients' attention elsewhere by holding their hand.
No Intervention: Control Group
In the control group, intramuscular injection will be performed by the clinic nurse. All intramuscular injections will be performed by a single nurse and the ventrogluteal region will be used as the injection site. Patients will first fill out the Voluntary Information and Consent Form, and then the Descriptive Characteristics Form and State Anxiety Scale. After the injection site is assessed, the nurse will enter the tissue at a 90-degree angle and administer the medication slowly (1 ml/10 seconds). After removing the needle from the tissue, the nurse will apply pressure with dry cotton. After the procedure, the Numerical Pain Scale and State Anxiety Scale will be filled in within 1 minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Pain Scale
Time Frame: It will be filled within 1 minute after the intramuscular injection is completed.
A score of "0" indicated the lowest pain, and a score of "10" indicated the highest pain.
It will be filled within 1 minute after the intramuscular injection is completed.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State Anxiety Scale
Time Frame: It will be filled immediately before the intramuscular injection and within 1 minute after the procedure is completed.
A score between 20-80 is obtained. The highest score obtained from the scale indicates a high level of anxiety, while a low score indicates a low level of anxiety.
It will be filled immediately before the intramuscular injection and within 1 minute after the procedure is completed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Necmettin Erbakan University

Investigators

  • Study Chair: Serpil SU, Necmettin Erbakan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 3, 2024

Primary Completion (Estimated)

October 15, 2024

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

May 12, 2024

First Submitted That Met QC Criteria

May 12, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 12, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Necmettin Erbakan U

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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