Effect of Hand Holding on Reducing Intramuscular Injection-Induced Pain and Anxiety: A Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Necmettin Erbakan University
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Numerical Pain Scale
Study Overview
Brief Summary
It was aimed to examine the effect of the hand holding method applied during intramuscular injection on pain and anxiety.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Hand Holding (Other)
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.
Outcomes
Primary Outcomes
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
- State Anxiety Scale(It will be filled immediately before the intramuscular injection and within 1 minute after the procedure is completed.)
Investigators
Serpil SU
Assistant professors
Necmettin Erbakan University