Effects of Voice Records on Patient Outcomes Surgical Intensive Care Unit

NCT07007754 | Completed DMC

• 1 other identifier: Voice Record
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit Patients; Pain Management; Stress Response

Keywords

Abdominal surgery; intensive care unite; nursing care; voice record

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

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

Study Arms (3)

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.

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.

Procedure: Voice recording playback

Control group

NO INTERVENTION

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

Interventions

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.

Family voice records; Notr voice record

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Zafer Mahallesi, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Fractures, Stress

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Research Assisstant (Principal Investigator)

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 6, 2025
• Study Start: May 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 15, 2022
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after publication

Locations

TU (1)