Nursing CariesNCT05569616
Hand Massage and Play Activity in the Elderly
A study testing Hand massage and Play activity in people with Nursing Caries, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
There is no study found that examined the effects of hand massage and play activity on the loneliness, comfort and psychological well-being of the elderly in nursing homes. This study was planned as a pretest-posttest randomized controlled dual center study in order to examine the effects of hand massage and play… Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries
- What is being tested?
- Hand massage and Play activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Be in the age range of 65-84 years
- Being literate
- No visual or hearing impairment
- Ability to communicate verbally
- Loss of sensation in the hand, arthritis, phlebitis, inflammation, eczema and fracture, etc. absence
- Absence of any finger or limb loss
Show all 10Show fewer
- A score of 25 and above on the Standardized Mini Mental Test
- Not having been diagnosed with a mental illness such as Parkinson's, Alzheimer's or major depression
- Staying in a nursing home for at least three weeks
- Agreeing to participate in the research
Who cannot join
- Being 85 years or older
- Having sensory problems in the hands
- Having hand and nail deformities
- Having an open wound or burn on the hands
- Loss of limbs in fingers
- Don't have neuropathy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Nursing home
Mersin
Aysun Kazak, MSc, +90 5513883318, aysn1108@gmail.com
About this study
Official title: Investigation of the Effect of Hand Massage and Play Activity on Loneliness, Comfort and Psychological Well-Being Levels in the Elderly
There is no study found that examined the effects of hand massage and play activity on the loneliness, comfort and psychological well-being of the elderly in nursing homes. This study was planned as a pretest-posttest randomized controlled dual center study in order to examine the effects of hand massage and play activity on loneliness, comfort and psychological well-being in the elderly. 60 elderly people living in two nursing homes in Mersin city center will form the sample of the study. The sample will consist of three groups as hand massage group, game activity group and control group. The data were using the "Elderly Information Form", "Standardized Mini-Mental Test", "Loneliness Scale fort he Elderly", "General Comfort Scale", "Warwick-Edinburgh Mental Well-Being Scale", "Hand Massage" and "Play Activity (Jenga) will be collected. Hand massage group will be applied hand massage for 20 minutes for four weeks; the game activity group will play Jenga (game activity) for one hour a week. The control group will receive the institution's standart of care. Frequency, number, mean, Student's test and/or Mann-Whitney U test, ANOVA and/or Kruskal-Wallis test, Chi-square test and/or Correlation Analysis will be used in the analysis of the data. As a result of this research, the effects and benefits of hand massage and play activity on the loneliness, comfort and psychological well-being levels of the elderly living in nursing homes will be determined, and it is anticipated that these effects and benefits will be included in evidence-based guidlines.
- Conditions
- Nursing Caries
- Being tested
- Hand massage, Play activity
- Keywords
- Hand massage Play activity Psychological well-being Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand massageOther
Hand massage is a simple comfort intervention that involves touch and conveys care that can easily be incorporated independently into routine nursing care activities. Hand massage is a western technique that includes five basic classical massage manipulations, including eufluorage, petrissage, friction, tapotman and vibration. Kolcaba et al. (2006) hand massage procedure will be applied with baby oil for 20 minutes, three times a week (12 times in total) for 4 weeks.
Play activityOther
The number of people for the Jenga game was determined as two people in order to strengthen the social relationship among the elderly and to strengthen their psychomotor skills. Each game will be played with two people. For this reason, the elderly will be divided into five separate groups, two people each.These groups will be played the Jenga game for one hour a week on a certain day of the week, accompanied by the researcher, during the activity hours determined by the nursing home. After the game activity (Jenga) application is completed at the end of the fourth week, the post-test scales will be re-administered to the elderly by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| Hand massage group | Experimental | Based on the hand massage procedure, hand massage with baby oil will be applied for 20 minutes, three times a week (12 times in total) for 4 weeks. Receives: Other: Hand massage |
| Play activity group | Experimental | It will be played in groups of two for one hour once a week. The application will take 4 weeks. Receives: Other: Play activity |
| Control group | No intervention | These elderly people in the control group will benefit from the standard care practices offered in the institution, and no intervention will be given to these elderly people by the researcher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elderly Introduction Form
In this form, which was created by the researchers by scanning the literature; A total of 14 questions aimed at determining the introductory characteristics of the elderly (age, gender, marital status, education level, occupation, number of children, income level, place of residence, smoking and alcohol use, chronic disease diagnosis, duration, medications used, and length of stay in a nursing home) is located.
Measured: First day
Standardized Mini Mental Test
The standardized version of the original Mini Mental Test developed by Folstein et al. (1975) by Molloy and Standish (1997) is an easy-to-apply test that provides information about the degree of cognitive impairment. This test consists of "orientation, recording, attention, calculation, reminder, language tests and configuration" sections. Test; It is a test that can be administered by physicians, nurses and psychologists in a short time (10 minutes), outpatient conditions or at the bedside. The test was developed for the purpose of short-term cognitive assessment in the elderly, especially in the examination of delirium or dementia.
Measured: will be applied on the first day. If the Standardized Mini Mental Test result is not 25 points or more, the patient will be excluded.
Loneliness Scale for the Elderly
It is a measurement tool developed based on the cognitive behavioral approach. The scale, which has 11 items in total, consists of two sub-dimensions, "Emotional Loneliness" and "Social Loneliness":
Measured: First week
Loneliness Scale for the Elderly
It is a measurement tool developed based on the cognitive behavioral approach. The scale, which has 11 items in total, consists of two sub-dimensions, "Emotional Loneliness" and "Social Loneliness":
Measured: Forth week
General Comfort Scale
The levels of the scale, which was formed by taking the taxonomic structure, which includes three levels and four dimensions that constitute the theoretical components of comfort, as a guide; relief (16 items), relief (17 items) and overcoming problems (15 items). Scale dimensions are; physical dimension (12 items), psychospiritual dimension (13 items), environmental dimension (13 items) and sociocultural dimension (10 items).
Measured: First week
General Comfort Scale
The levels of the scale, which was formed by taking the taxonomic structure, which includes three levels and four dimensions that constitute the theoretical components of comfort, as a guide; relief (16 items), relief (17 items) and overcoming problems (15 items). Scale dimensions are; physical dimension (12 items), psychospiritual dimension (13 items), environmental dimension (13 items) and sociocultural dimension (10 items).
Measured: Forth week
Warwick-Edinburgh Mental Well-Being Scale
Scale, Tennant et al. (2007) in order to determine the mental well-being levels of the people of England. The scale is a one-dimensional, 14-item, 5-point Likert scale. Participants respond as "1 = I do not agree at all, 2 = I do not agree, 3 = I agree somewhat, 4 = I agree, 5 = I completely agree).
Measured: First week
Warwick-Edinburgh Mental Well-Being Scale
Scale, Tennant et al. (2007) in order to determine the mental well-being levels of the people of England. The scale is a one-dimensional, 14-item, 5-point Likert scale. Participants respond as "1 = I do not agree at all, 2 = I do not agree, 3 = I agree somewhat, 4 = I agree, 5 = I completely agree).
Measured: Forth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Aug 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies 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
- Model description
- The research was planned as a pre-test-post-test randomized controlled and single-center study in order to examine the effects of hand massage and play activity on loneliness, comfort and psychological well-being in the elderly.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYSUN KAZAK, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569616
- Sponsor's protocol ID
- AKAZAK.TEZ-KTÜ
- Status last verified
- Oct 2022
- First submitted
- 28 Sep 2022
- Last updated
- 6 Oct 2022
- 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 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Hand Massage and Play Activity on Loneliness, Comfort and Psychological Well-Being Levels in the Elderly
- ClinicalTrials.gov ID
- NCT05569616
- Acronym / sponsor ID
- AKAZAK.TEZ-KTÜ
- Conditions
- Nursing Caries
- Keywords
- Hand massage Play activity Psychological well-being Elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Oct 2022 (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.
There is no study found that examined the effects of hand massage and play activity on the loneliness, comfort and psychological well-being of the elderly in nursing homes. This study was planned as a pretest-posttest randomized controlled dual center study in order to examine the effects of hand massage and play activity on loneliness, comfort and psychological well-being in the elderly. 60 elderly people living in two nursing homes in Mersin city center will form the sample of the study. The sample will consist of three groups as hand massage group, game activity group and control group. The data were using the "Elderly Information Form", "Standardized Mini-Mental Test", "Loneliness Scale fort he Elderly", "General Comfort Scale", "Warwick-Edinburgh Mental Well-Being Scale", "Hand Massage" and "Play Activity (Jenga) will be collected. Hand massage group will be applied hand massage for 20 minutes for four weeks; the game activity group will play Jenga (game activity) for one hour a week. The control group will receive the institution's standart of care. Frequency, number, mean, Student's test and/or Mann-Whitney U test, ANOVA and/or Kruskal-Wallis test, Chi-square test and/or Correlation Analysis will be used in the analysis of the data. As a result of this research, the effects and benefits of hand massage and play activity on the loneliness, comfort and psychological well-being levels of the elderly living in nursing homes will be determined, and it is anticipated that these effects and benefits will be included in evidence-based guidlines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The research was planned as a pre-test-post-test randomized controlled and single-center study in order to examine the effects of hand massage and play activity on loneliness, comfort and psychological well-being in the elderly.
| Arm | Type | Receives |
|---|---|---|
| Hand massage group | Experimental | Other: Hand massageBased on the hand massage procedure, hand massage with baby oil will be applied for 20 minutes, three times a week (12 times in total) for 4 weeks. |
| Play activity group | Experimental | Other: Play activityIt will be played in groups of two for one hour once a week. The application will take 4 weeks. |
| Control group | No intervention | –These elderly people in the control group will benefit from the standard care practices offered in the institution, and no intervention will be given to these elderly people by the researcher. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Be in the age range of 65-84 years
- Being literate
- No visual or hearing impairment
- Ability to communicate verbally
- Loss of sensation in the hand, arthritis, phlebitis, inflammation, eczema and fracture, etc. absence
Key exclusion criteria (6 listed)
- Being 85 years or older
- Having sensory problems in the hands
- Having hand and nail deformities
- Having an open wound or burn on the hands
- Loss of limbs in fingers
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 is a simple comfort intervention that involves touch and conveys care that can easily be incorporated independently into routine nursing care activities. Hand massage is a western technique that includes five basic classical massage manipulations, including eufluorage, petrissage, friction, tapotman and vibration. Kolcaba et al. (2006) hand massage procedure will be applied with baby oil for 20 minutes, three times a week (12 times in total) for 4 weeks. | Other | Hand massage group |
| Play activityThe number of people for the Jenga game was determined as two people in order to strengthen the social relationship among the elderly and to strengthen their psychomotor skills. Each game will be played with two people. For this reason, the elderly will be divided into five separate groups, two people each.These groups will be played the Jenga game for one hour a week on a certain day of the week, accompanied by the researcher, during the activity hours determined by the nursing home. After the game activity (Jenga) application is completed at the end of the fourth week, the post-test scales will be re-administered to the elderly by the researcher. | Other | Play activity group |
Primary outcome
Elderly Introduction Form
Time frame: First day
In this form, which was created by the researchers by scanning the literature; A total of 14 questions aimed at determining the introductory characteristics of the elderly (age, gender, marital status, education level, occupation, number of children, income level, place of residence, smoking and alcohol use, chronic disease diagnosis, duration, medications used, and length of stay in a nursing home) is located.
Standardized Mini Mental Test
Time frame: will be applied on the first day. If the Standardized Mini Mental Test result is not 25 points or more, the patient will be excluded.
The standardized version of the original Mini Mental Test developed by Folstein et al. (1975) by Molloy and Standish (1997) is an easy-to-apply test that provides information about the degree of cognitive impairment. This test consists of "orientation, recording, attention, calculation, reminder, language tests and configuration" sections. Test; It is a test that can be administered by physicians, nurses and psychologists in a short time (10 minutes), outpatient conditions or at the bedside. The test was developed for the purpose of short-term cognitive assessment in the elderly, especially in the examination of delirium or dementia.
Loneliness Scale for the Elderly
Time frame: First week
It is a measurement tool developed based on the cognitive behavioral approach. The scale, which has 11 items in total, consists of two sub-dimensions, "Emotional Loneliness" and "Social Loneliness":
Loneliness Scale for the Elderly
Time frame: Forth week
It is a measurement tool developed based on the cognitive behavioral approach. The scale, which has 11 items in total, consists of two sub-dimensions, "Emotional Loneliness" and "Social Loneliness":
General Comfort Scale
Time frame: First week
The levels of the scale, which was formed by taking the taxonomic structure, which includes three levels and four dimensions that constitute the theoretical components of comfort, as a guide; relief (16 items), relief (17 items) and overcoming problems (15 items). Scale dimensions are; physical dimension (12 items), psychospiritual dimension (13 items), environmental dimension (13 items) and sociocultural dimension (10 items).
General Comfort Scale
Time frame: Forth week
The levels of the scale, which was formed by taking the taxonomic structure, which includes three levels and four dimensions that constitute the theoretical components of comfort, as a guide; relief (16 items), relief (17 items) and overcoming problems (15 items). Scale dimensions are; physical dimension (12 items), psychospiritual dimension (13 items), environmental dimension (13 items) and sociocultural dimension (10 items).
Warwick-Edinburgh Mental Well-Being Scale
Time frame: First week
Scale, Tennant et al. (2007) in order to determine the mental well-being levels of the people of England. The scale is a one-dimensional, 14-item, 5-point Likert scale. Participants respond as "1 = I do not agree at all, 2 = I do not agree, 3 = I agree somewhat, 4 = I agree, 5 = I completely agree).
Warwick-Edinburgh Mental Well-Being Scale
Time frame: Forth week
Scale, Tennant et al. (2007) in order to determine the mental well-being levels of the people of England. The scale is a one-dimensional, 14-item, 5-point Likert scale. Participants respond as "1 = I do not agree at all, 2 = I do not agree, 3 = I agree somewhat, 4 = I agree, 5 = I completely agree).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- 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.
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 and Play activity in people with Nursing Caries, run by Mersin 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 10 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elderly Introduction Form (time frame: First day). The study lists 8 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 6 Oct 2022.