Effect of Hand Holding on Pain and Anxiety

Pain and Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06417047
• Other study ID #: Necmettin Erbakan U
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: April 15, 2025

Study information

• Verified date: May 2024
• Source: Necmettin Erbakan University
• Contact: Serpil SU
• Phone: 05052611380
• Email: ssu[@]erbakan.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: April 15, 2025
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Pain and Anxiety

Intervention

Other:
• Hand Holding
During the intramuscular injection, the aim is to draw the patients' attention elsewhere by holding their hand.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Pain Scale	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	State Anxiety Scale	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.