NCT05569616

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

2.3 years

First QC Date

September 28, 2022

Last Update Submit

October 4, 2022

Conditions

Keywords

Hand massage Play activity Psychological well-being Elderly

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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":

    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":

    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).

    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).

    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).

    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).

    Forth week

Study Arms (3)

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.

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.

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.

Interventions

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.

Hand massage group

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.

Play activity group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nursing home

Mersin, Turkey (Türkiye)

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 6, 2022

Study Start

August 1, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

October 6, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations