Psychosocial Nursing Interventions on Sleep, Anxiety and Delirium in Patients Undergoing Open Heart Surgery

NCT05864482 | Unknown DMC

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine the effects of psychosocial nursing interventions applied to a patient with cardiac surgery on sleep quality, anxiety and delirium. Are psychosocial nursing interventions applied to a patient with cardiac surgery effective in preventing delirium? Are psychosocial nursing interventions applied to a patient with cardiac surgery effective on sleep quality? Are psychosocial nursing interventions applied to a patient with cardiac surgery effective on the level of anxiety?

Conditions

Delirium

Keywords

psychosocial nursing interventions; sleep; anxiety; delirium

Outcome Measures

Primary Outcomes (3)

• Change from baseline in sleep quality on the Richard Campell Sleep Quality Scale at two days

  This scale, developed by Richards, is a 6-item scale that measures the depth of night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment. Each item is evaluated on a chart with numbers from 0 to 100. According to the scale scoring, "0-25" points indicate very bad sleep, while "76-100" points indicate very good sleep. The 6th item, which evaluates the noise level in the environment, is excluded from the scale total score evaluation, and the total score is evaluated over 5 items. As the score of the scale increases, the sleep quality of the patients also increases.

  Baseline and two days

• Change from baseline in pain on the Visual Analog Scale at two days

  Developed by Price et al. (1983), this scale is one of the commonly used pain measurement tools in health research due to its ease of use and simple structure. The scale consists of a 10 cm ruler on which there is no pain on one end and excruciating pain on the other end, on which the patient marks the pain. The distance between the point where the patient marked the pain and the pain-free interval is measured in cm and recorded. Cline et al., in their study to standardize the VAS, determined that the vertical use of the VAS was better understood by the patients.

  Baseline and two days

• Change from baseline in anxiety on the State Anxiety Scale at two days

  The State-Trait Anxiety Inventory was developed by Spielberger et al. in 1970 to measure state anxiety and trait anxiety. The Turkish validity and reliability study of the scale was performed by Le Compte and Öner in 1983. The "state anxiety" to be used in this study is the subjective fear that the individual feels due to the stressful situation he is in. The state anxiety scale is an easy-to-apply inventory consisting of 20 questions that the individual can answer himself. The individual is asked to mark one of the statements (1) "not at all", (2) "somewhat", (3) "a lot", and (4) "completely", evaluating how he or she feels "at the moment". If the lowest score that can be obtained at the end of the scale is 20, the highest score is 80. In the evaluation, 0-19 points are interpreted as "no anxiety", 20-39 points as "mild anxiety", 40-59 points as "moderate anxiety", 60-79 points as "severe anxiety" and 80 points as "panic value".

  Baseline and two days

Secondary Outcomes (2)

• Change from baseline in delirium on the Confusion Evaluation in Intensive Care Scale at two days

  Baseline and two days

• Change from baseline in agitation on the Richmand Sedation Agitation Scale at two days

  Baseline and two days

Study Arms (2)

Experimental

EXPERIMENTAL

Brief Cognitive behavioral therapy intervention will be interviewed by the researcher as part of psychosocial care, with two sessions pre-operative and two post-operative sessions. In the postoperative period, an eye mask and ear plug will be applied to the patient by the researcher on the 3rd and 4th days of the short CBT post-op and between 23:00 and 07:00 at night. Visual Analogue Scale, State Anxiety Inventory, Richmond Agitation-Sedation Scale, Confusion Evaluation Scale in Intensive Care, Richard Campbell Sleep Quality Scale, Daily Follow-up Form will be applied after open heart surgery.

Other: Psychosocial nursing intervention

Control

NO INTERVENTION

Patients who meet the research criteria and agree to participate in the study will be informed about the research process (purpose of the research, assignment to the intervention and control group, etc.), written informed consent and contact information of the patients will be obtained, and the contact information of the researcher will be given to the patient. Only routine nursing care will be given to the patient. will be applied by the researcher

Interventions

Psychosocial nursing intervention OTHER

The sessions were planned to be at least 45 minutes in a time suitable for the groups, with the bed curtains drawn if possible. Session 1: The purpose of this session; Brief CIS information will be provided. Session 2: The session starts with mood control of individuals. It is discussed whether they have experienced an event that occupies their minds and is likely to affect their illness. Session 3: It starts with mood control of individuals. They are asked if there is anything from the places where the guests are. Cognitive reviews are reviewed. It aims to describe recent stressful observations, negative automatic outcome descriptions, and evaluation of such experiences. 4.Session: The session starts with the mood control of the patient. It is discussed whether the patient has experienced an event that occupies his mind. Continuous analysis of negative thoughts and review of cognitive techniques and coping mechanisms are provided.

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 15 April - 31 August 2023, Mersin University Hospital cardiovascular surgery service, cardiovascular surgery intensive care unit was admitted,
• over the age of 18,
• Patients who will undergo open heart surgery for the first time,
• Not diagnosed with any psychiatric disease,
• Conscious, cooperative, hemodynamically stable (blood pressure not below 70/50mHg), not on mechanical ventilator
• Patients with a state anxiety scale score of 40 and above,
• Low and medium risk patients evaluated with the European System for Cardiac Operative Risk Evaluation (EuroSkor), the risk scoring system used to predict mortality in the preoperative period in cardiac surgery,
• Literate, with sufficient communication skills and Turkish-speaking
• Those who signed the Informed Consent Form to participate in the study will be included.

You may not qualify if:

• Between 15 April - 31 August 2023, Mersin University Hospital cardiovascular surgery service, cardiovascular surgery intensive care unit was admitted,
• Emergency patients for whom open heart surgery has not been planned before,
• Diagnosed with dementia,
• Standardized mini mental test (SMMT) below 3 points,
• Has a history of previous cerebrovascular accident (CVO),
• Severe comorbidity
• Patients with a high EuroScore and prolonged mechanical ventilator duration
• Those who do not sign the Informed Consent Form to participate in the study will not be included.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Firdevs Ebru ÖZDEMİR

Mersin, Yenişehir, 33110, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Delirium; Anxiety Disorders

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mualla YILMAZ, PhD

  Prof. Dr.

  STUDY DIRECTOR

Central Study Contacts

Firdevs Ebru ÖZDEMİR, Master

CONTACT

+90505 854 2080; februliozd@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Nurse

Model Details: Randomized Controlled Study

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: May 9, 2023
• Primary Completion: October 30, 2023
• Study Completion: November 30, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

TU (1)