Use of Comfort Theory In Intensive Care

NCT06781671 | Completed

• 1 other identifier: SAÜ-SBE-FK-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Nursing interventions, which has been configured to conform In this study, the mutual comfort needs of intensive care patients that were supported by various materials such as tablet computers and remote video call systems ,which was configured according to the comfort theory and applied to patients in the form of nursing interventions.. It was planned to examine that the effects of nursing interventions which was structured according to the comfort theory, applied to patients on the comfort levels of the patients and their perceived environmental stressor levels.

Conditions

Intensive Care Unit

Keywords

Comfort Theory; Nursing Care; Video Interview; Radio-Television; Environmental Stress

Outcome Measures

Primary Outcomes (1)

• Are supportive nursing care interventions structured according to Kolcaba's Comfort Theory more effective than standard nursing care in increasing patients' comfort levels?

  Supportive nursing care structured according to the comfort theory applied to intensive care patients for 48 hours increased the comfort level of patients. General Comfort Scale: The Turkish validity and reliability study of the General Comfort Scale developed by Katharine Kolcaba in 1992 was conducted by Kuguoglu and Karabacak. The scale is a four-point Likert-type and consists of 48 items. The comfort levels of the scale are relief (16 items), relaxation (17 items) and superiority (15 items). The scale consists of positive and negative items and these items are mixed. The highest total score that can be obtained from the scale is 192, while the lowest total score is 48. Low comfort is expressed with one point and high comfort is expressed with four points. In the validity and reliability study, the Cronbach alpha coefficient of the scale was found to be 0.85. For this study group, the Cronbach alpha coefficient of the scale was found to be 0.91.

  Minimum 48 hours

Secondary Outcomes (1)

• Are supportive nursing care interventions structured according to Kolcaba's Comfort Theory effective in reducing environmental stress compared to standard nursing care?

  Minimum 48 hours

Study Arms (2)

Control

NO INTERVENTION

Patients in the control group were subjected to standard intensive care conditions Routine monitoring and treatments were administered. Repositioning was performed for patients in need every two hours within the bed Visits were conducted daily with a maximum duration of five minutes per patient, allowing only one family member to be present face-to-face. Each night at 01:00, a routine chest X-ray was taken\*, and routine blood samples\*\* were collected at 03:00. Mobilization was not carried out during the day unless deemed necessary. Patients did not receive any materials such as tablet computers, sleep masks, or sleep headphones The Patient Identification Form, General Comfort Scale, and Intensive Care Unit Environmental Stressor Scale were administered face-to-face by the researcher 48 hours after the patient admission to the intensive care unit. = Since the researched department is the intensive care unit for chest diseases, routine chest X-rays are taken from patients every nigt

Intervention

EXPERIMENTAL

Structured nursing interventions based on the Comfort Theory were applied to patients in the intervention group. Patients were mobilized at least once during the day. Auxiliary materials believed to increase patient comfort, such as tablet computers, wired headphones, sleep headphones, and sleep masks, were provided. Patients had face-to-face meetings with their families during the day and video calls in the evening. Care interventions were minimized as much as possible for patients between 24:00-07:00 at night, and treatments were carefully planned around these hours. Blood sampling was performed at 23:00 at night, and X-rays were taken at 07:00 in the morning. The Patient Identification Form, General Comfort Scale, and Intensive Care Unit Environmental Stressor Scale were administered face-to-face by the researcher 48 hours after the patient\'s admission to the intensive care unit.

Behavioral: ComfortTheory

Interventions

ComfortTheory BEHAVIORAL

Structured nursing interventions based on the Comfort Theory were applied to patients in the intervention group. Patients were mobilized at least once during the day. Auxiliary materials believed to increase patient comfort, such as tablet computers, wired headphones, sleep headphones, and sleep masks, were provided. Patients had face-to-face meetings with their families during the day and video calls in the evening. Care interventions were minimized as much as possible for patients between 24:00-07:00 at night, and treatments were carefully planned around these hours. Blood sampling was performed at 23:00 at night, and X-rays were taken at 07:00 in the morning. The Patient Identification Form, General Comfort Scale, and Intensive Care Unit Environmental Stressor Scale were administered face-to-face by the researcher 48 hours after the patient\'s admission to the intensive care unit.

Also known as: Intervention Group

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 18 years old or older
• Requiring intensive care treatment for at least 48 hours
• Being literate
• Having no sensory losses such as vision, hearing, or speech impairments
• Being open to communication and collaboration
• Currently undergoing treatment in the intensive care unit
• Approval from both the patient and the family to participate in the study
• Sufficient knowledge on the part of the patient\'s family for remote video communication

You may not qualify if:

• Refusing consent at any stage of the study and withdrawing from the study
• Being intubated
• Having cognitive disorders such as dementia, Alzheimer\'s, and Parkinson\'s
• Discharged from the intensive care unit before 48 hours

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya Universty

Sakarya, Serdivan, 54100, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The groups will be divided into two based on hospital protocol numbers. Those with an even protocol number will be included in the intervention group, while those with an odd number will be included in the control group.

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: January 17, 2025
• Study Start: October 23, 2019
• Primary Completion: April 2, 2020
• Study Completion: June 15, 2021
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)