Sleep QualityNCT06872008
Hand Massage Applied To Elderly Stayıng In Nursing Homes
A study testing Hand Massage in people with Sleep Quality and Anxiety Level, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
Hand massage; behavioral and reduce psychological symptoms, enable individuals to calm down and relax, and provide individual and care It is applied to contribute to communication between donors, to ensure reliability and ease of application, to improve the quality of life and to reduce symptoms such as sleep… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Anxiety Level
- What is being tested?
- Hand Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Nov 2024to 30 Dec 2024
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being suitable for participation in the study according to the institution's psychosocial report
- Being a nursing home resident and being 60 years of age or older
- Not having been diagnosed with Alzheimer's or dementia
- Being able to speak and understand Turkish
- Not having problems with sensory perception and communication skills
- Not having any problems with applying hand massage
- Giving consent to participate in the study.
Who cannot join
- Having a cognitive problem
- Hand and nail deformities with thrombus, phlebitis, ecchymosis, hematoma, impaired skin integrity to be,
- Using antidepressant, hypnotic, benzodiazepine and narcotic derivative drugs that affect sleep quality.
- Criteria for Discontinuation from Follow-up:
- Wanting to leave after the research has started.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Hand Massage Applied To Elderly Stayıng In Nursing Homes On Sleep Quality and Anxiety Level: Randomized Controlled Trial
Hand massage; behavioral and reduce psychological symptoms, enable individuals to calm down and relax, and provide individual and care It is applied to contribute to communication between donors, to ensure reliability and ease of application, to improve the quality of life and to reduce symptoms such as sleep problems, fatigue, pain, stress, anxiety and depression that the individual frequently experiences.
This study will be carried out to determine the effect of hand massage on the sleep quality and anxiety level of elderly people living in nursing homes.
Read more
The number of samples of the research G-Power 3.1.9.7 program was used in the calculation. In the analysis, the average scores of the Pittsburgh Sleep Quality Scale were used and 58 individuals (29 experimental, 29 control) were required.
In the research, it was aimed to assign 30 people to each group, taking into account the high power of the test and the losses.
Hand massage in the literature Although there is no standard duration for how long to apply, studies have shown that the massage is applied for an average of 5-10 times, and in this study, the massage application time was It was determined as 10 minutes in total, 5 minutes for each hand. Hand massage with baby oil will be performed 3 times a week for 4 weeks, for a total of 12 sessions.
Research data, Diagnostic Information Form, Pittsburgh Sleep Quality Index (PSQI), Trait Anxiety Scale It will be collected using (STAI-TX). The data obtained from the research were analyzed in the Statistical Package for Social Science (SPSS) 21 statistical program.
will be done. Variables covering the descriptive characteristics of individuals with chronic diseases are expressed in numbers and percentages.
will be done. Whether the data has a normal distribution will be determined by the Shapiro-Wilk test and parametric and/or non-parametric tests will be used depending on the results obtained. Statistical significance value will be accepted as p<05.
Read the detailed description
Hand massage application consists of five basic classical massages including efflorage, petrissage, friction, tapotman and vibration.
It is a massage that includes manipulation and is performed with western technique. Hand massage; behavioral and psychological symptoms, to enable individuals to calm down and relax, to contribute to communication between individuals and caregivers, to ensure ease of application, to improve quality of life, and to reduce symptoms such as sleep problems, fatigue, pain, stress, anxiety and depression that the individual frequently experiences. is implemented. Easily learned Its important advantages are that it is applicable, non-invasive, does not require position changes and does not cause privacy violations.
- Conditions
- Sleep Quality, Anxiety Level
- Being tested
- Hand Massage
- Keywords
- HAND MASSAGE, SLEEP QUALITY, ANXIETY LEVEL, NURSING HOME, RANDOMIZED CONTROLLED STUDY, ELDERLY
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand MassageBehavioural
Hand massage to elderly people Hand massage application consists of five basic classical massages including efflorage, petrissage, friction, tapotman and vibration.
It is a massage that includes manipulation and is performed with western technique.
The researcher will collaborate with the institution's physiotherapist throughout the application. Hand massage in the literature Although there is no standard duration for how long the massage should be applied, studies have shown that the massage is applied for an average of 5-10 times, and in this study the massage application time was It was determined as 10 minutes in total, 5 minutes for each hand. Hand massage with baby oil will be performed 3 times a week for 4 weeks, for a total of 12 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Participant Group | Experimental | Hand Massage Receives: Behavioral: Hand Massage |
| Control Group | No intervention | No Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report measure that evaluates sleep quality and disturbance over the past month.
is the scale. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency,Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbance,Sleeping Drug Use and Daytime Dysfunction. Each A component is evaluated on a scale of 0-3 points. The total score of the 7 components gives the scale total score. Total score varies between 0-21. Your total score is less than 5being large indicates "poor sleep quality"
Measured: Baseline and week 4
STAI-TX Anxiety Scale
The transformed expressions in the Trait Anxiety Inventory constitute items 21, 26, 27, 30, 33, 36 and 39. After having the total weights of direct and uttered expressions separately, subtracting the reverse expressions in terms of total weight from the total weight score obtained for direct expressions. A clearly determined and unchanging value is added to this number. The last value obtained is the person's anxiety. The Trait Anxiety Scale (SCSS) indicates that the person shows a persistent level of anxiety about life in general. Scores range from 20 (low anxiety) to 80 (high anxiety)
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start18 Nov 2024
- Primary completion20 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba, Amasya University
- Investigators
- Tuğba Sarı, MSc, Principal investigator, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872008
- Sponsor's protocol ID
- AUSBFTSARI001
- Status last verified
- Mar 2025
- First submitted
- 26 Nov 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Hand Massage Applied To Elderly Stayıng In Nursing Homes On Sleep Quality and Anxiety Level: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06872008
- Acronym / sponsor ID
- AUSBFTSARI001
- Conditions
- Sleep Quality, Anxiety Level
- Keywords
- HAND MASSAGE, SLEEP QUALITY, ANXIETY LEVEL, NURSING HOME, RANDOMIZED CONTROLLED STUDY, ELDERLY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 12 Mar 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.
Hand massage; behavioral and reduce psychological symptoms, enable individuals to calm down and relax, and provide individual and care It is applied to contribute to communication between donors, to ensure reliability and ease of application, to improve the quality of life and to reduce symptoms such as sleep problems, fatigue, pain, stress, anxiety and depression that the individual frequently experiences.
This study will be carried out to determine the effect of hand massage on the sleep quality and anxiety level of elderly people living in nursing homes.
The number of samples of the research G-Power 3.1.9.7 program was used in the calculation. In the analysis, the average scores of the Pittsburgh Sleep Quality Scale were used and 58 individuals (29 experimental, 29 control) were required.
In the research, it was aimed to assign 30 people to each group, taking into account the high power of the test and the losses.
Hand massage in the literature Although there is no standard duration for how long to apply, studies have shown that the massage is applied for an average of 5-10 times, and in this study, the massage application time was It was determined as 10 minutes in total, 5 minutes for each hand. Hand massage with baby oil will be performed 3 times a week for 4 weeks, for a total of 12 sessions.
Research data, Diagnostic Information Form, Pittsburgh Sleep Quality Index (PSQI), Trait Anxiety Scale It will be collected using (STAI-TX). The data obtained from the research were analyzed in the Statistical Package for Social Science (SPSS) 21 statistical program.
will be done. Variables covering the descriptive characteristics of individuals with chronic diseases are expressed in numbers and percentages.
will be done. Whether the data has a normal distribution will be determined by the Shapiro-Wilk test and parametric and/or non-parametric tests will be used depending on the results obtained. Statistical significance value will be accepted as p<05.
Detailed description
Hand massage application consists of five basic classical massages including efflorage, petrissage, friction, tapotman and vibration.
It is a massage that includes manipulation and is performed with western technique. Hand massage; behavioral and psychological symptoms, to enable individuals to calm down and relax, to contribute to communication between individuals and caregivers, to ensure ease of application, to improve quality of life, and to reduce symptoms such as sleep problems, fatigue, pain, stress, anxiety and depression that the individual frequently experiences. is implemented. Easily learned Its important advantages are that it is applicable, non-invasive, does not require position changes and does not cause privacy violations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant Group | Experimental | Behavioral: Hand MassageHand Massage |
| Control Group | No intervention | –No Massage |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being suitable for participation in the study according to the institution's psychosocial report
- Being a nursing home resident and being 60 years of age or older
- Not having been diagnosed with Alzheimer's or dementia
- Being able to speak and understand Turkish
- Not having problems with sensory perception and communication skills
Key exclusion criteria (5 listed)
- Having a cognitive problem
- Hand and nail deformities with thrombus, phlebitis, ecchymosis, hematoma, impaired skin integrity to be,
- Using antidepressant, hypnotic, benzodiazepine and narcotic derivative drugs that affect sleep quality.
- Wanting to leave after the research has started.
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 MassageHand massage to elderly people Hand massage application consists of five basic classical massages including efflorage, petrissage, friction, tapotman and vibration. It is a massage that includes manipulation and is performed with western technique. The researcher will collaborate with the institution's physiotherapist throughout the application. Hand massage in the literature Although there is no standard duration for how long the massage should be applied, studies have shown that the massage is applied for an average of 5-10 times, and in this study the massage application time was It was determined as 10 minutes in total, 5 minutes for each hand. Hand massage with baby oil will be performed 3 times a week for 4 weeks, for a total of 12 sessions. | Behavioural | Participant Group |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: Baseline and week 4
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report measure that evaluates sleep quality and disturbance over the past month. is the scale. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency,Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbance,Sleeping Drug Use and Daytime Dysfunction. Each A component is evaluated on a scale of 0-3 points. The total score of the 7 components gives the scale total score. Total score varies between 0-21. Your total score is less than 5being large indicates "poor sleep quality"
STAI-TX Anxiety Scale
Time frame: Baseline and week 4
The transformed expressions in the Trait Anxiety Inventory constitute items 21, 26, 27, 30, 33, 36 and 39. After having the total weights of direct and uttered expressions separately, subtracting the reverse expressions in terms of total weight from the total weight score obtained for direct expressions. A clearly determined and unchanging value is added to this number. The last value obtained is the person's anxiety. The Trait Anxiety Scale (SCSS) indicates that the person shows a persistent level of anxiety about life in general. Scores range from 20 (low anxiety) to 80 (high 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 12 Mar 2025.
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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.
Tuğba Sarı, MSc principal investigator
Amasya University
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 in people with Sleep Quality and Anxiety Level, run by Amasya 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 7 inclusion and 5 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 12 Mar 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?
Pittsburgh Sleep Quality Index (time frame: Baseline and week 4). The study lists 2 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 12 Mar 2025.