Therapeutic Touch for Intramuscular Injection Pain

June 24, 2026 updated by: Gülistan YURDAGÜL, Kilis 7 Aralik University

Effect of Therapeutic Touch on Intramuscular Injection Pain: A Randomized Controlled Trial

The purpose of this study is to evaluate the effect of therapeutic touch on pain intensity associated with intramuscular injection and to examine the relationship between fear of pain and injection-related pain. Participants are assigned to either a therapeutic touch group or a control group. Pain intensity is assessed using a Visual Analog Scale (VAS), and fear of pain is assessed using the Fear of Pain Questionnaire.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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 Locations

  • Turkey (Türkiye)
    • Kilis
      • Kilis, Kilis, Turkey (Türkiye), 79000
        • Kilis 7 Aralık University, School of Health Services

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between 18 and 60 years of age,
  • Being literate,
  • Being able to complete the Fear of Pain Questionnaire (FPQ) without missing items,
  • Having no known allergy or contraindication to pheniramine hydrogen maleate,
  • Not having lower respiratory tract disease/asthma and not being in pregnancy or lactation period,
  • Having normal consciousness (adequate orientation and ability to follow commands),
  • Not having a severe mood disorder.

Exclusion Criteria:

  • Incomplete completion of the questionnaire/scale during the study,
  • Having medical conditions that may affect pain perception, such as peripheral vascular disease, peripheral neuropathy, or diabetes.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Therapeutic Touch
In the intervention group, a supportive touch intervention was applied during the intramuscular injection to provide emotional support to the patient. Immediately before the injection, the researcher demonstrated the procedure to the patient's companion with a brief example and provided guidance on how the hand should be held. During the injection, the companion held the patient's hand with both hands, offering a calm, silent, and supportive presence. Throughout this process, the nurse was responsible only for administering the intramuscular injection and ensuring clinical safety; the nurse did not participate in the intervention. After the injection was completed, the patient's pain level was assessed using the VAS scale based on self-report.
Behavioral: Supportive Hand-Holding
This intervention involves supportive hand-holding by the patient's companion during the intramuscular injection. Immediately before the injection, the researcher briefly demonstrated to the companion how the hand should be held and provided simple guidance. During the injection, the companion held the patient's hand with both hands, offering a calm, silent, and emotionally supportive presence. The nurse was responsible only for administering the intramuscular injection and monitoring clinical safety; the nurse did not participate in the intervention itself. After the injection, the patient's pain level was assessed using the VAS scale based on self-report.
Other Names:
  • Therapeutic Touch
No Intervention: Control Group
Participants in this group received no additional intervention; the intramuscular injection was administered in accordance with routine clinical practice. After the injection was completed, the patient's pain level was assessed using the same VAS scale based on self-report, as in the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain Intensity (VAS Score)
Time Frame: Immediately after the intramuscular injection (within 2 minutes).
Immediately after the intramuscular injection (within 2 minutes).

Collaborators and Investigators

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

Sponsor

Kilis 7 Aralik 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 (Actual)

May 3, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

June 24, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E.45023

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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