- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05569616
Hand Massage and Play Activity in the Elderly
October 4, 2022 updated by: AYSUN KAZAK, Mersin University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- 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
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-
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Mersin, Turkey
- Recruiting
- Nursing home
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Contact:
- Aysun Kazak, MSc
- Phone Number: +90 5513883318
- Email: aysn1108@gmail.com
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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
Ages Eligible for Study
65 years to 85 years (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Hand massage group
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.
|
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.
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EXPERIMENTAL: Play activity group
It will be played in groups of two for one hour once a week.
The application will take 4 weeks.
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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.
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NO_INTERVENTION: Control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Elderly Introduction Form
Time Frame: First day
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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.
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First day
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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.
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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.
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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.
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Loneliness Scale for the Elderly
Time Frame: First week
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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":
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First week
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Loneliness Scale for the Elderly
Time Frame: Forth week
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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":
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Forth week
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General Comfort Scale
Time Frame: First week
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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).
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First week
|
|
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).
|
Forth week
|
|
Warwick-Edinburgh Mental Well-Being Scale
Time Frame: First week
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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).
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First week
|
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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).
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Forth week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 1, 2022
Primary Completion (ANTICIPATED)
December 1, 2024
Study Completion (ANTICIPATED)
December 1, 2024
Study Registration Dates
First Submitted
September 28, 2022
First Submitted That Met QC Criteria
October 4, 2022
First Posted (ACTUAL)
October 6, 2022
Study Record Updates
Last Update Posted (ACTUAL)
October 6, 2022
Last Update Submitted That Met QC Criteria
October 4, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- AKAZAK.TEZ-KTÜ
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
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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