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Clinical Trials/NCT07007754
NCT07007754CompletedNot Applicable

Effects of Voice Records on Vital Signs, Pain and Serum Cortisol Levels in Surgical Intensive Care Unit: Randomized-controlled Study

Aydin Adnan Menderes University2 sites in 1 country69 target enrollmentStarted: May 1, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
69
Locations
2
Primary Endpoint
Pain level

Study Overview

Brief Summary

This randomized kontrolled study is aimed to contribute to the literature on recognising, evaluating and reducing stress in the intensive care unit, which is one of the main responsibilities of surgical nurses, and to increase awareness on the subject.

Detailed Description

The condition of having surgery, the severity of the disease, being admitted to the intensive care unit in the postoperative period and the presence of many invasive interventions in the body, intense feelings of pain and fear, loss of autonomy, helplessness, and fear of death create a heavy physical, psychological and emotional burden on patients undergoing surgery. All these factors increase the stress level in the patient by causing many metabolic and hormonal changes, and as a result of this stress response, negative conditions such as hyperglycaemia, delay in recovery, and decreased immunity can be seen.

Nurses have main roles and responsibilities in intensive care settings such as caring for patients, participating in treatment, informing and counselling patients and their relatives. Within the scope of these roles and responsibilities, nurses should be aware of the stress experienced by patients, recognise the factors that may cause stress, plan, implement and evaluate basic nursing interventions such as increasing coping strategies and social support in the management and alleviation of stress, informing and counselling, increasing the patients orientation, and enabling the patient to participate in care in order to reduce the level of stress experienced by patients and protect their physical and biopsychosocial integrity.

There are no studies in the literature examining the effects of listening to audio recordings, which is an easy, inexpensive and non-pharmacological intervention for stress management of patients in intensive care units.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • To determined as being over 18 years of age,
  • To staying in the ICU for at least two hours,
  • To being hospitalised in the ICU for the first time,
  • To being able to speak and understand Turkish.

Exclusion Criteria

  • To determined as being pregnant,
  • To having a diagnosis of neurological/psychiatric disorder,
  • To having hearing problems,
  • To using cortisol-derived drugs,
  • To having a disease that may affect serum cortisol level, exhibiting agitated behaviour and
  • To experiencing intense nausea and vomiting.

Outcomes

Primary Outcomes

Pain level

Time Frame: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.

A numerical rating scale was used to evaluate the pain. The scale was marked from 0 to 10 based on the patient's self-report. 0 indicates no pain, while 10 points indicates unbearable pain.

Blood pressure

Time Frame: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.

Since the patients were monitored in the intensive care unit and invasive blood pressure measurements were performed, the values monitored on the Mindray patient monitor were added to the data collection form.

Serum cortisol level

Time Frame: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.

The serum cortisol level in the blood was reported in an independent private laboratory by taking a blood sample.

Blood glucose level

Time Frame: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.

The blood glucose level was assessed using Gluko Navi brand glucometer with fingertip measurement.

Hearth rate

Time Frame: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.

Since the patients were monitored in the intensive care unit and pulse rate was measured, the values monitored on the Mindray patient monitor were added to the data collection form.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Aydin Adnan Menderes University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ezgi Arslan

PhD, Research Assisstant (Principal Investigator)

Aydin Adnan Menderes University

Study Sites (2)

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