Effects of Improved Environment on Sleep, Anxiety-Depression

NCT06744023 | Completed

• 1 other identifier: 2023/09-17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Disease; Cardiovascular Diseases

Keywords

Open heart surgery; anxiety; depression; improved environment; sleep quality; sleep duration

Outcome Measures

Primary Outcomes (3)

• Improved sleep quality with optimised environment

  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

  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

  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

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

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.

CONTROL GROUP

NO INTERVENTION

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.

Interventions

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. OTHER

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)

Also known as: Improve environment

EXPERIMENTAL GROUP

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hatice AZİZOĞLU: lead

Study Sites (1)

Yüzüncü Yil University

Van, Turkey (Türkiye)

Location

Related Publications (15)

• Nicholson G, Gandra SR, Halbert RJ, Richhariya A, Nordyke RJ. Patient-level costs of major cardiovascular conditions: a review of the international literature. Clinicoecon Outcomes Res. 2016 Sep 21;8:495-506. doi: 10.2147/CEOR.S89331. eCollection 2016.

  PMID: 27703385 RESULT

• Yin L, Rong T, Zhang Y, Gao J. The relationship between sleep quality and anxiety and depression among older caregivers of centenarians in China: A cross-sectional study. Geriatr Nurs. 2023 Nov-Dec;54:302-309. doi: 10.1016/j.gerinurse.2023.10.005. Epub 2023 Oct 31.

  PMID: 37918038 RESULT

• Frontini R, Rebelo-Goncalves R, Amaro N, Salvador R, Matos R, Morouco P, Antunes R. The Relationship Between Anxiety Levels, Sleep, and Physical Activity During COVID-19 Lockdown: An Exploratory Study. Front Psychol. 2021 Mar 30;12:659599. doi: 10.3389/fpsyg.2021.659599. eCollection 2021.

  PMID: 33859601 RESULT

• Demir B, Saritas S. The relationship between anxiety and stress levels with quality of sleep in patients after living donor liver transplantation. Transpl Immunol. 2022 Apr;71:101561. doi: 10.1016/j.trim.2022.101561. Epub 2022 Feb 25.

  PMID: 35219827 RESULT

• Nyer M, Farabaugh A, Fehling K, Soskin D, Holt D, Papakostas GI, Pedrelli P, Fava M, Pisoni A, Vitolo O, Mischoulon D. Relationship between sleep disturbance and depression, anxiety, and functioning in college students. Depress Anxiety. 2013 Sep;30(9):873-80. doi: 10.1002/da.22064. Epub 2013 May 16.

  PMID: 23681944 RESULT

• Tian Y. A review on factors related to patient comfort experience in hospitals. J Health Popul Nutr. 2023 Nov 8;42(1):125. doi: 10.1186/s41043-023-00465-4.

  PMID: 37941052 RESULT

• Wei Q, Lee JH, Park HJ. Novel design of smart sleep-lighting system for improving the sleep environment of children. Technol Health Care. 2019;27(S1):3-13. doi: 10.3233/THC-199002.

  PMID: 31045522 RESULT

• Delaney LJ, Currie MJ, Huang HC, Lopez V, Van Haren F. "They can rest at home": an observational study of patients' quality of sleep in an Australian hospital. BMC Health Serv Res. 2018 Jul 5;18(1):524. doi: 10.1186/s12913-018-3201-z.

  PMID: 29976191 RESULT

• Yelden K, Duport S, Kempny A, Playford ED. A rehabilitation unit at night: environmental characteristics of patient rooms. Disabil Rehabil. 2015;37(1):91-6. doi: 10.3109/09638288.2014.906662. Epub 2014 Apr 1.

  PMID: 24689441 RESULT

• Matsumoto Y, Uchimura N, Ishida T, Morimatsu Y, Mori M, Inoue M, Kushino N, Hoshiko M, Ishitake T. The relationship of sleep complaints risk factors with sleep phase, quality, and quantity in Japanese workers. Sleep Biol Rhythms. 2017;15(4):291-297. doi: 10.1007/s41105-017-0110-1. Epub 2017 Jul 21.

  PMID: 28989323 RESULT

• Gimenez MC, Geerdinck LM, Versteylen M, Leffers P, Meekes GJ, Herremans H, de Ruyter B, Bikker JW, Kuijpers PM, Schlangen LJ. Patient room lighting influences on sleep, appraisal and mood in hospitalized people. J Sleep Res. 2017 Apr;26(2):236-246. doi: 10.1111/jsr.12470. Epub 2016 Nov 10.

  PMID: 27862514 RESULT

• Falci SG, Marques LS. CONSORT: when and how to use it. Dental Press J Orthod. 2015 May-Jun;20(3):13-5. doi: 10.1590/2176-9451.20.3.013-015.ebo. No abstract available.

  PMID: 26154451 RESULT

• Norman V, Rossillo K, Skelton K. Creating Healing Environments Through the Theory of Caring. AORN J. 2016 Nov;104(5):401-409. doi: 10.1016/j.aorn.2016.09.006.

  PMID: 27793250 RESULT

• Sarrafzadegan N, Mohammmadifard N. Cardiovascular Disease in Iran in the Last 40 Years: Prevalence, Mortality, Morbidity, Challenges and Strategies for Cardiovascular Prevention. Arch Iran Med. 2019 Apr 1;22(4):204-210.

  PMID: 31126179 RESULT

• Azizoglu H, Gurkan Z, Bozkurt Y, Demir C, Akaltun H. The Effect of an Improved Environment According to Watson's Theory of Human Care on Sleep, Anxiety, and Depression in Patients Undergoing Open Heart Surgery: A Randomized Controlled Trial. Healthcare (Basel). 2025 Jan 18;13(2):183. doi: 10.3390/healthcare13020183.

  PMID: 39857209 DERIVED

MeSH Terms

Conditions

Coronary Disease; Cardiovascular Diseases; Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• HATİCE AZİZOĞLU

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A randomised controlled trial. 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.

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: December 20, 2024
• Study Start: October 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

TU (1)