StrokeNCT06808906
The Effect of Hand Massage on Pain, Anxiety, and Comfort Levels of Intensive Care Patients
A study testing Hand Massage Application in people with Stroke, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Hand Massage Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Stroke
- Being tested
- Hand Massage Application
- Keywords
- hand massage, pain, anxiety, comfort, Intensive care unit, nursing
- Medical subject headings
- Stroke, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Massage ApplicationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Hand massage application steps were based on Kolcaba's Comfort Theory, and the protocol was followed accordingly Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 15 minutes and 60 minutes after 10 minutes of hand massage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start20 May 2023
- Primary completion20 Aug 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Havva SERT, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808906
- Sponsor's protocol ID
- SAÜ-HAND MASSAGE
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hand Massage on Pain, Anxiety, and Comfort Levels of Intensive Care Patients
- ClinicalTrials.gov ID
- NCT06808906
- Acronym / sponsor ID
- SAÜ-HAND MASSAGE
- Conditions
- Stroke
- Keywords
- hand massage, pain, anxiety, comfort, Intensive care unit, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Hand Massage ApplicationHand massage application steps were based on Kolcaba's Comfort Theory, and the protocol was followed accordingly |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand Massage ApplicationHand 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 | Other | Intervention |
Primary outcome
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Massage Application in people with Stroke, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Pain Scale (VAS) (time frame: 15 minutes and 60 minutes after 10 minutes of hand massage). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.