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

January 30, 2025 updated by: Havva SERT, Sakarya University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Serdivan
      • Sakarya, Serdivan, Turkey, 54000
        • Sakarya University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Pain Scale (VAS)
Time Frame: 15 minutes and 60 minutes after 10 minutes of hand massage
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)
Time Frame: 15 minutes and 60 minutes after 10 minutes of hand massage
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)
Time Frame: 15 minutes and 60 minutes after 10 minutes of hand massage
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sakarya 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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