Clinical trial NCT07007754: Effects of Voice Records on Patient Outcomes Surgical Intensive Care Unit
Official title: Effects of Voice Records on Vital Signs, Pain and Serum Cortisol Levels in Surgical Intensive Care Unit: Randomized-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Patients
Pain Management
Stress Response
Keywords: Abdominal surgery
intensive care unite
nursing care
voice record
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain level
timeFrame: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.
measure: Blood pressure
timeFrame: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.
measure: Serum cortisol level
timeFrame: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.
measure: Blood glucose level
timeFrame: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.
measure: Hearth rate
timeFrame: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydın Adnan Menderes University
state: Zafer Mahallesi
Study officials:
References: