NCT05791903

Brief Summary

Nurses aim to care for people who can no longer carry out their life activities and needs, and to ensure that they can continue to live their lives as well as possible. The aim is to improve the quality of life by making life more comfortable through care. Comfort in care means solving the patient's problems, being peaceful and content, and relieving pain/suffering. Kolcaba explained that comfort theory can be used as a guide to meet the comfort needs of individuals in the care process. The theory explains the concept of comfort as relaxation, refreshment and the ability to overcome problems (superiority). According to this theory, the nurse identifies the comfort needs of the patient and family and plans and implements interventions to meet these needs. There are no studies in the literature that have investigated the effect of nursing care based on Kolcaba's comfort theory on the comfort, satisfaction and sleep quality of ICU patients. The aim of this study is to determine the effect of nursing care based on Kolcaba's Comfort Theory on the comfort, satisfaction and sleep quality of ICU patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 3, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

March 7, 2023

Last Update Submit

June 12, 2024

Conditions

Keywords

comfortsatisfactionquality of sleep

Outcome Measures

Primary Outcomes (3)

  • General Comfort Scale

    The scale, which was developed by Katharine Kolcaba in 1992 in order to determine the comfort needs of individuals, to evaluate the nursing initiatives that can provide comfort and the increase in comfort, was adapted to Turkish society by Kuğuoğlu and Karabacak in 2004.The scale, which is a four-point Likert-type scale with 48 items, was created by guiding the taxonomic structure consisting of the theoretical components of comfort, including 3 levels and 4 dimensions. Level; While the dimension is evaluated as relief (16 items), relief (17 items) and overcoming the problems (15 items); It is evaluated in three parts: physical (12 items), psychospritual (13 items) and socio-cultural (10 items). Negative expressions in the scale are calculated by reverse coding during the evaluation phase. While the lowest total score that can be obtained from the scale is 48, the highest total score is 192.

    24 hours later

  • Comfort Behaviors Checklist

    The Comfort Behaviour Checklist was developed by Katharina Kolcaba in 1989. The checklist is completed by the observer when it is not possible for the person to complete the questionnaire. The Comfort Behaviour Checklist consists of 30 behavioural indicators. In addition to these, Kolcaba suggests that if the checklist is the only tool used to measure comfort, the individual should give a numerical score for pain and comfort so that comfort can be objectively assessed.

    24 hours later

  • Richard-Campbell Sleep Scale

    The scale was developed by Richards et al. (1987) to assess sleep quality in intensive care units (Richards, 1987; Richards et al., 2000). The RQAS includes six items (depth of sleep, time to fall asleep, frequency of awakening, duration of wakefulness, quality of sleep and ambient noise level). The scale score is evaluated with the sum of the first five items. A score of 25 and below indicates very poor sleep, while a minimum score of 76 and above indicates very good sleep.

    24 hours later

Study Arms (2)

Experimental Group

EXPERIMENTAL

In the application process, individuals in the experimental group will receive care based on Kolcaba's comfort theory and comfort behaviour checklist during their stay in the ICU.

Other: Nursing Care Based on Kolcaba's Comfort Theory

Control Group

NO INTERVENTION

In this study, the control group will receive standard care.

Interventions

Comfort-orientated care

Experimental Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to participate in the research,
  • years of age or older,
  • Being open to communication,
  • Clear state of consciousness
  • Staying in the intensive care unit for at least 24 hours

You may not qualify if:

  • The patient is taking sedative medication
  • Being diagnosed with a sleep disorder,
  • The use of sleeping pills,
  • Loss of hearing and/or vision
  • Use of a hearing aid
  • Dependence on mechanical ventilator
  • illiteracy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van yüzüncü yıl university

Van, 65100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient SatisfactionPersonal SatisfactionSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Aylin ÖZAKGÜL, PhD

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
randomized
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Experimental, randomised controlled, single-blind study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 30, 2023

Study Start

May 3, 2023

Primary Completion

July 5, 2023

Study Completion

June 6, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Locations