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

NCT06808906 | Completed

• 1 other identifier: SAÜ-HAND MASSAGE
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Stroke

Keywords

hand massage; pain; anxiety; comfort; Intensive care unit; nursing

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Hand massage application steps were based on Kolcaba's Comfort Theory, and the protocol was followed accordingly

Other: Hand Massage Application

Control

NO INTERVENTION

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.

Interventions

Hand Massage Application OTHER

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

Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University

Sakarya, Serdivan, 54000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients who met the inclusion criteria were divided into two groups: intervention and control. The groups were randomized according to the protocol numbers of the patients in a computerized environment. Patients in the intervention group were informed about the procedure before starting the massage.

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: May 20, 2023
• Primary Completion: August 20, 2023
• Study Completion: October 30, 2023
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)