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NCT Number: NCT07007754

Effects of Voice Records on Patient Outcomes Surgical Intensive Care Unit

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.

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Key information

Conditions

Intensive Care Unit Patients Agnosia Fractures, Bone Fractures, Stress Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Stress Response Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aydın Adnan Menderes University

Aydin, Zafer Mahallesi, 09010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Voice recording playback

Procedure

Voice recordings were created from a text containing 12 standardised messages common to both the patient's relatives and the researcher and expert opinion was obtained in terms of the applicability of the created text. Before the intervention, the postoperative patient's suitability was determined by the patient's statement and the researcher's observations. No intervention was performed if the patient had nausea/vomiting, pain or agitation before the intervention. Kingboss 8 Gb+ 650 hours uninterrupted digital voice recorder and headphones were used for voice recording. When the voice recorder and headphones were to be used in a different patient, they were wiped with 70% alcohol and used after waiting for 2 minutes in accordance with the manufacturer's instructions. The voice of one of the family members was recorded for Intervention group-1 patients and the voice of one of the researchers was (nötr voice) recorded for intervention group-2.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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