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

Status

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

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.

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 (Anticipated)

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.
60

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
      • Mersin, Turkey
        • Recruiting
        • Nursing home
        • Contact:

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

65 years to 85 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Be in the age range of 65-84 years
  2. Being literate
  3. No visual or hearing impairment
  4. Ability to communicate verbally
  5. Loss of sensation in the hand, arthritis, phlebitis, inflammation, eczema and fracture, etc. absence
  6. Absence of any finger or limb loss
  7. A score of 25 and above on the Standardized Mini Mental Test
  8. Not having been diagnosed with a mental illness such as Parkinson's, Alzheimer's or major depression
  9. Staying in a nursing home for at least three weeks
  10. Agreeing to participate in the research

Exclusion Criteria:

  1. Being 85 years or older
  2. Having sensory problems in the hands
  3. Having hand and nail deformities
  4. Having an open wound or burn on the hands
  5. Loss of limbs in fingers
  6. 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

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: 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.
Other: Hand massage
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.
EXPERIMENTAL: Play activity group
It will be played in groups of two for one hour once a week. The application will take 4 weeks.
Other: Play activity
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.
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.

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
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.
First day
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.
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
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":
First week
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":
Forth week
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).
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
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).
First week
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).
Forth week

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.
Mersin 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.
August 1, 2022

Primary Completion (ANTICIPATED)

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.
December 1, 2024

Study Completion (ANTICIPATED)

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.
December 1, 2024

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).
September 28, 2022

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.
October 4, 2022

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.
October 6, 2022

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.
October 6, 2022

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.
October 4, 2022

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.
October 1, 2022

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.
  • 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings