NCT06872008

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 18, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2024

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

November 26, 2024

Last Update Submit

March 6, 2025

Conditions

Keywords

HAND MASSAGESLEEP QUALITYANXIETY LEVELNURSING HOMERANDOMIZED CONTROLLED STUDYELDERLY

Outcome Measures

Primary Outcomes (2)

  • 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"

    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)

    Baseline and week 4

Study Arms (2)

Participant Group

EXPERIMENTAL

Hand Massage

Behavioral: Hand Massage

Control Group

NO INTERVENTION

No Massage

Interventions

Hand MassageBEHAVIORAL

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.

Participant Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University

Amasya, 05100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Tuğba Sarı, MSc

    Amasya University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 26, 2024

First Posted

March 12, 2025

Study Start

November 18, 2024

Primary Completion

December 20, 2024

Study Completion

December 30, 2024

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations