Intensive Care Unit PatientsNCT07007754
Effects of Voice Records on Patient Outcomes Surgical Intensive Care Unit
A study testing Voice recording playback in people with Intensive Care Unit Patients and Pain Management, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Patients, Pain Management, Stress Response
- What is being tested?
- Voice recording playback
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 15 May 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University
Aydin, Zafer Mahallesi, 09010
About this study
Official title: Effects of Voice Records on Vital Signs, Pain and Serum Cortisol Levels in Surgical Intensive Care Unit: Randomized-controlled Study
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.
Read the 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.
- Being tested
- Voice recording playback
- Keywords
- Abdominal surgery, intensive care unite, nursing care, voice record
- Medical subject headings
- Agnosia, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice recording playbackProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Family voice records | Experimental | In addition to the general care provided by health professionals in ICU, the intervention group-1 listen to family voice records. Receives: Procedure: Voice recording playback |
| Notr voice record | Experimental | In addition to the general care provided by health professionals in ICU, the intervention group-1 listen to nötr voice records. Receives: Procedure: Voice recording playback |
| Control group | No intervention | The control group received general care provided by healthcare professionals in the ICU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
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.
Measured: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.
Blood pressure
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.
Measured: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.
Serum cortisol level
The serum cortisol level in the blood was reported in an independent private laboratory by taking a blood sample.
Measured: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.
Blood glucose level
The blood glucose level was assessed using Gluko Navi brand glucometer with fingertip measurement.
Measured: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.
Hearth rate
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.
Measured: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 May 2021
- Primary completion30 Apr 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Arslan, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007754
- Sponsor's protocol ID
- Voice Record
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.