NCT07050901

Brief Summary

A randomised controlled study will be conducted to determine the effect of nursing care based on Kolcaba's comfort theory on the quality of life and psychological well-being levels of the elderly.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

June 4, 2025

Last Update Submit

July 2, 2025

Conditions

Keywords

quailty of lifenursingpsychological well-beingelderly

Outcome Measures

Primary Outcomes (1)

  • experimental group measurement

    measurement of quality of life and psychological well-being levels of the elderly up to 5 months with a questionnaire form

    September 2023

Secondary Outcomes (1)

  • control group measurement

    December 2023

Study Arms (2)

Experiment group

EXPERIMENTAL

The experimental group will receive training on Nursing Care Based on Kolcaba's Comfort Theory. For the individuals in the experimental group, follow-up measurements will be made in the 1st month and 3rd month after the completion of Kolcaba's Nursing Care Based on Comfort Theory training.

Other: Nursing Care Based on Kolcaba's Comfort Theory

Control group

NO INTERVENTION

The control group continued to receive the routine care

Interventions

Kolcaba's Nursing Care Applications Based on Comfort Theory were carried out individually; each application was planned for one and a half hours, one day a week and for 8 weeks, and each session was carried out for each individual through home visits. The topics of Nursing Care Based on Kolcaba's Comfort Theory were; Physical Care Practices (2 weeks), Psychospiritual Care Practices (2 weeks), Environmental Care Practices (2 weeks) and Sociocultural Care Practices (2 weeks).

Experiment group

Eligibility Criteria

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

You may qualify if:

  • Volunteered to participate in the research,
  • Residing in Aydın,
  • No mental disability,
  • years of age or older,
  • At least primary school graduate (since the scales should be filled in by self-report method),
  • individuals who can speak and write Turkish language were included.

You may not qualify if:

  • individuals staying in nursing homes/nursing homes were excluded from the scope of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AydınAdnan Menderes University institute of health sciences

Aydin, Efeler, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

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

Study Record Dates

First Submitted

June 4, 2025

First Posted

July 3, 2025

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

June 30, 2025

Last Updated

July 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request

Shared Documents
CSR
Time Frame
6 months after publication
Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations