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Completed

NCT Number: NCT06417047

Effect of Hand Holding on Pain and Anxiety

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hand Holding

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 16, 2024
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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