Effects of Improved Environment on Sleep, Anxiety-Depression

December 18, 2024 updated by: Hatice AZİZOĞLU

The Effect of Improved Envıronment Accordıng to Watson's Theory of Human Care on Sleep, Anxıety, and Depressıon ın Patıents Undergoıng Open Heart Surgery: A Randomızed Controlled Study

The aim of this randomized controlled trial was to examine the effect of an improved environment on sleep, anxiety, and depression in patients undergoing open heart surgery. This study aims to answer the following main questions:

  • According to Watson's Human Care Theory, what is the effect of the improved environment on patients' sleep level and sleep quality?
  • According to Watson's Human Care Theory, what is the effect of the improved environment on patients' anxiety and depression levels?

In order to observe the effect of the improved environment on sleep, anxiety, and depression, the researchers ensured that the room temperature, humidity, and lumen range of the light were at the appropriate level in the first 3 days after the surgery of the patients in the experimental group and gradually decreased them gradually.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this randomized controlled trial was to examine the effect of an improved environment on sleep, anxiety, and depression in patients undergoing open heart surgery. This study aims to answer the following main questions:

  • According to Watson's Human Care Theory, what is the effect of the improved environment on patients' sleep level and sleep quality?
  • According to Watson's Human Care Theory, what is the effect of the improved environment on patients' anxiety and depression levels? Before collecting data for this study, the "G. Power-3.1.9.2" program calculated the sample size at an 80% confidence level. The "Sample Calculation Formula with Known Universe (Population Volume)" (n = Nz2pq / d2(N-1) + z2pq) determined the sample. The literature review determined the "effect size" value to be 0.096. Taking the primary type error of 5% (Z = 1,96), the test power of 80%, and the effect size value of 0,096 units, we calculated the minimum sample size as n = 60. Therefore, the study included 60 volunteer patients, with 30 placed in the experimental group and 30 in the control group.

Data were collected using the Personal Information Form, the Richard-Campbell Sleep Questionnaire (RCSQ), and the Hospital Anxiety and Depression (HAD) Scale.

The patients who underwent open heart surgery and who were in the experimental group were admitted to the ward from the postoperative intensive care unit and the environment was improved for three days based on the improved environment of Watson's HCT, and on the morning of the fourth day in the clinic, the patients were interviewed face to face and the Personal Information Form, RSCQ and HAD Scale were completed. The following improvements were implemented within the scope of environmental improvement:

  • Considering the seasonal conditions, the patient room was ensured to have appropriate temperature (18-26 °C) and humidity values (30-60%), and the temperature and humidity were gradually reduced and maintained in the appropriate range by monitoring at 21:00, 22:00, and 23:00 (Days 1, 2, and 3).
  • In line with the environmental arrangements, the brightness of the light in the patient room was gradually reduced at 21:00, 22:00, and 23:00 using the Light Meter LM-3000 (Days 1, 2, and 3).

Characteristics of the measuring instrument and application

  • The humidity and temperature of the patient room were measured with a Digital-Clock Humidity Meter and Thermometer Device. The Digital-Clock Humidity Meter and Thermometer is a digital thermo-hygrometer that displays indoor temperature and humidity values. The device can stand on the desktop or hang on the wall. The device displays temperature and humidity values, and it also stores the highest and lowest values in its memory. Temperature measurement units can be selected as 0°C or 0°F. The temperature measurement range is -10 to +600, and the accuracy is ± 1 °C. The humidity measurement range of the device with a temperature resolution of 0.1 °C is between 10 and 99%. The humidity sensitivity is ±5%, and the humidity resolution rate is 1%. The device's dimensions are (L) 102 x (W) 21 x (H) 110 mm. It weighed 122 grams.
  • The luminous intensity of the light in the patient room was measured with the Light Meter LM-3000 mobile application provided by the researcher. Luminous intensity is the amount of luminous flux per unit area of a surface per unit time. E represents it, lux serves as its unit, and a luxmeter measures it. By definition, we divide the luminous flux of the surface by its area (E = lumen/m2). Light Meter LM-3000 is a mobile application that measures the illuminance of light in lux. Its measurement algorithm offers unrivaled precision to capture the slightest lighting changes, opening up new possibilities in light pollution and health research. Developed by optical scientists and engineers and compatible with five languages, the Light Meter LM-3000 is calibrated using professional Class A equipment for all iPhones and iPads.

The patients in the control group continued to receive standard treatment and care. On the morning of the fourth day after the patients were admitted to the ward from the postoperative intensive care unit, the patients were interviewed face-to-face and the Personal Information Form, RCSQ, and HAD Scale were completed.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Van, Turkey
        • Yuzuncu Yil University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients between the ages of 18 and 65 who have undergone open heart surgery and who are conscious and willing to communicate and cooperate.

Exclusion Criteria:

  • Patients younger than 18 years and older than 65 years who did not want to participate in the study voluntarily

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EXPERIMENTAL GROUP
Upon admission to the ward from the postoperative intensive care unit, the experimental group underwent environmental remediation for three days. The environmental arrangements ensured that the patient room maintained an appropriate temperature range of 18-26 °C and humidity values of 30-60%. Monitoring took place at 21:00, 22:00, and 23:00 on Days 1, 2, and 3. On Days 1, 2, and 3, the patient room's light brightness gradually decreased at 21:00, 22:00, and 23:00. On the morning of the fourth day, the patients were interviewed face-to-face, and the research questionnaires were filled out.
Other: To examine the effect of the improved environment according to Watsons Human Care Theory on sleep quality, anxiety, and depression in patients undergoing open heart surgery.

The patients who underwent open heart surgery and who were in the experimental group were admitted to the ward from the postoperative intensive care unit and the environment was improved for three days based on the improved environment of Watson's HCT, and on the morning of the fourth day in the clinic, the patients were interviewed face to face and the Personal Information Form, RSCQ and HAD Scale were completed. The following improvements were implemented within the scope of environmental improvement:

  • Considering the seasonal conditions, the patient room was ensured to have appropriate temperature (18-26 °C) and humidity values (30-60%), and the temperature and humidity were gradually reduced and maintained in the appropriate range by monitoring at 21:00, 22:00, and 23:00 (Days 1, 2, and 3)
  • In line with the environmental arrangements, the brightness of the light in the patient room was gradually reduced at 21:00, 22:00, and 23:00 using the Light Meter LM-3000 (Days 1, 2, and 3)
Other Names:
  • Improve environment
No Intervention: CONTROL GROUP
The patients in the control group continued to receive standard treatment and care. On the morning of the fourth day after the patients were admitted to the ward from the postoperative intensive care unit, the patients were interviewed face-to-face and the Personal Information Form, RCSQ, and HAD Scale were completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved sleep quality with optimised environment
Time Frame: The first three days after transfer from intensive care to the ward
This outcome measure assesses how the improved environment affects postoperative sleep quality with the Richard-Campbell Sleep Questionnaire (RCSQ).
The first three days after transfer from intensive care to the ward
Improvement in anxiety levels with improved environment
Time Frame: The first three days after transfer from intensive care to the ward
This outcome measure assesses how the improved environment affects postoperative anxiety with the Hospital Anxiety and Depression (HAD) Scale.
The first three days after transfer from intensive care to the ward
Improvement in depression levels with improved environment
Time Frame: The first three days after transfer from intensive care to the ward
TThis outcome measure assesses how the improved environment affects postoperative depression with the Hospital Anxiety and Depression (HAD) Scale.
The first three days after transfer from intensive care to the ward

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hatice AZİZOĞLU

Investigators

  • Principal Investigator: HATİCE AZİZOĞLU, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/09-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The datasets used to support the findings of this study are available from the corresponding author upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe