Effect of Hand Holding on Pain and Anxiety

NCT06417047 | Completed DMC

• 1 other identifier: Necmettin Erbakan U
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain and Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• State Anxiety Scale

  It will be filled immediately before the intramuscular injection and within 1 minute after the procedure is completed.

Study Arms (2)

Hand Holding Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Hand Holding OTHER

During the intramuscular injection, the aim is to draw the patients' attention elsewhere by holding their hand.

Hand Holding Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Serpil SU

  Necmettin Erbakan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor) The patients will be informed about the study and their consent will be obtained without explaining which group they are in. Since the researcher manages the implementation process of the study, researcher blinding cannot be done. In addition, it will be ensured that the researcher learns which group the patients are in after the patients accept to participate in the study. Thus, the internal validity of the research will be ensured. At the same time, blind technique will be applied in terms of statistical analysis in the research. The data will be recorded on the computer by the researcher without using the expression of experimental and control groups, and data analysis will be done by another statistician other than the person who made the randomization.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professors

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 16, 2024
• Study Start: July 20, 2024
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)