The Effect of Hand Massage on Pain, Anxiety, and Comfort Levels of Intensive Care Patients

This study titled "Evaluation of the Effect of Hand Massage on Patients' Pain, Anxiety and Comfort Levels" aims to determine the effect of hand massage on patients in intensive care units. Our study is single-center and will continue until May 30, 2023. The study is designed to create an experimental and control group. Your patient is in the control group of the study. During the application period of the study, patients in the control group will be provided with routine nursing care and no additional nursing intervention will be applied. Patients in the intervention group of the study will be applied a total of 12 sessions of hand massage, 6 sessions per week (15 minutes each session).

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Hand Massage Application

Detailed Description

The study sample consisted of patients who were receiving treatment at the Neurology Intensive Care Unit of Sakarya University Training and Research Hospital between April and May 2023, who met the inclusion criteria and agreed to participate in the study. The patients were divided into an intervention group (n=32) that received 15-minute hand massage and a control group (n=32) that received routine nursing care. The Sociodemographic Data Form, Visual Pain Scale (VAS), General Comfort Scale-Short Form and Spielberger State-Trait Anxiety Inventory (STAI) were used to collect data. Inclusion Criteria

• Being 18 years of age or older
• Agreeing to participate in the study and having written permission
• Not having any cognitive, sensory or mental disorders
• Being able to speak and communicate in Turkish
• Being fully oriented to place, time and person
• Individuals to be included should not have conditions such as masses, loss of sensation, fractures or ingrown toenails in their hands

Exclusion Criteria

• Patients who do not agree to participate in the study
• Patients who want to leave the study during the research process will not be included.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Serdivan
    • Sakarya, Serdivan, Turkey, 54000
      • Sakarya University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals aged 18 years and over who agreed to participate in the study
• whose written consent was obtained
• who had no communication problems (hearing, vision, speech, and perception) were included in the study.

Exclusion Criteria:

• Patients who did not agree to participate in the study, who had conditions such as mass in the hand area, sensory loss, previous surgical operation, allergy or skin disease, fracture, and ingrown nail, and who could not complete 12 sessions were excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Hand massage application steps were based on Kolcaba's Comfort Theory, and the protocol was followed accordingly	Other: Hand Massage Application; Hand massage was applied for a total of 12 sessions in two weeks. Care was taken to perform the hand massage application outside the treatment and care hours, and it was performed in a quiet environment. The application was started from the same hand in the same patient in each session, and the same clinic nurse massaged all patients. Since the patients were in the intensive care unit, their vital signs were monitored 24. It was carefully monitored whether there was any change in vital signs during the massage. The patient's hand to be applied was placed on the pillow or bed. Clothes covering the upper extremity starting from the elbow area were removed. The patient was placed in a supine or semi-fowler position. The nurse practitioner took a standing position. She started the massage with effleurage, first on the back of the hand, then on the palm, from the fingertips towards the heart direction, placing the thumbs on the area to be treated and applying effleurage 5 times in a half-mo
No Intervention: Control; Individuals in the control group did not receive any intervention and received routine nursing care. The patients in the control group were administered VAS, GCS-SF, and STAI twice at 10-minute intervals on the first day after randomization and VAS, GCS-SF, and STAI two weeks later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Pain Scale (VAS)	It is a 10 cm horizontal or vertical line with different numbers on both ends (0=no pain, 10=most severe pain). In many studies, it is used as an easy-to-apply and understandable scale for the assessment of pain intensity. VAS is also used for the assessment of comfort.	15 minutes and 60 minutes after 10 minutes of hand massage
General Comfort Scale-Short Form (GCS-SF)	The scale has sub-dimensions of relief (9 items), ease (9 items), and transcendence (10 items). In the evaluation of the scale consisting of positive and negative items, negative items are reverse coded and summed. The highest total score that can be obtained from the scale is 112, and the lowest score is 28	15 minutes and 60 minutes after 10 minutes of hand massage
Spielberg State-Trait Anxiety Inventory (STAI)	The scale, which was developed based on the two-factor anxiety concept to determine the state and trait anxiety levels of individuals, consists of a total of 40 items and two separate sections. Two different sections determine transient-state (20 items) and trait (20 items) anxiety levels. The State Anxiety Scale (SAS) determines how the individual feels at a certain moment and in a certain situation, and the Trait Anxiety Scale (TAS) determines how the individual generally feels. A total of 20-80 points are obtained from these scales. The highest score obtained from the scale indicates a high level of anxiety. An increase in the total score obtained from the scale indicates a high level of anxiety.	15 minutes and 60 minutes after 10 minutes of hand massage

Collaborators and Investigators

• Sponsor: Sakarya University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2023
• Primary Completion (Actual): August 20, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: pain; comfort; anxiety; Intensive care unit; nursing; hand massage
• Other Study ID Numbers: SAÜ-HAND MASSAGE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No