Effects of Voice Records on Patient Outcomes Surgical Intensive Care Unit

NCT ID: NCT07007754

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-05-15

Brief Summary

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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

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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.

Conditions

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Intensive Care Unit Patients Pain Management Stress Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Family voice records

In addition to the general care provided by health professionals in ICU, the intervention group-1 listen to family voice records.

Group Type EXPERIMENTAL

Voice recording playback

Intervention Type 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.

Notr voice record

In addition to the general care provided by health professionals in ICU, the intervention group-1 listen to nötr voice records.

Group Type EXPERIMENTAL

Voice recording playback

Intervention Type 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.

Control group

The control group received general care provided by healthcare professionals in the ICU.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Voice recording playback

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Ezgi Arslan

PhD, Research Assisstant (Principal Investigator)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aydın Adnan Menderes University

Aydin, Zafer Mahallesi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Voice Record

Identifier Type: -

Identifier Source: org_study_id

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