The Effect of Virtual Reality and Music Therapy on Physiological Parameters and Anxiety

NCT06649617 | Completed DMC

• 1 other identifier: 223
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Aim: Invasive procedures such as intravenous , intramuscular and subcutaneous Injection practices are among the most frequently performed nursing interventions in ıntensive care units. However, although nursing interventions positively affect the clinical results of the patient, they can cause anxiety and pain. In recent years, music therapy and virtual reality, which are nonpharmacological methods, have been widely used in reducing pain and anxiety. Based on this information, this study was conducted as a randomized controlled experimental to evaluate the effects of virtual reality and music therapy on physiological parameters and anxiety in nursing ınterventions applied to ıntensive care patients. Methods:The research was conducted with 90 patient in intensive care unit. The patients in the sample group were randomly determined by the researcher as Control Group (Standard Procedure), Music Therapy Group and Virtual Reality Group. The selection of patients included in the study was made using a random number table. Research data were collected using a structured patient information form, VAS pain scale , and state and trait anxiety inventory.The data were analyzed using SPSS 25 program. Keywords: music therapy, virtual reality, nursing interventions, intensive care

Conditions

Pain; Anxiety; Physiological Parameter

Keywords

pain; anxiety; physiological parameter; intensive care; nursing interventions,; music threapy; virtual reality

Outcome Measures

Primary Outcomes (2)

• Pain severity

  Patients were informed about the Visual Analogue Scale. Visual Analogue Scale: The level of pain, which is one of the physiological parameters, will be evaluated with the VAS pain scale . The scale includes facial expressions that show the level of pain between 0 and 10.

  2 month

• physiological parameter values (pulse rate /minute, respiratory rate/minute, systolic and diastolic blood pressure mm/Hg, oxygen saturation %, body temperature oC)

  patients were informed about physiological parameters. Physiological parameter values (ulse rate /minute, respiratory rate/minute, systolic and diastolic blood pressure mm/Hg, oxygen saturation %, body temperature oC)

  2 month

Secondary Outcomes (1)

• Anxiety level

  2 month

Study Arms (3)

Control Group (Standard Procedure)

EXPERIMENTAL

Before the application of nursing interventions ( Intramuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Then , information was given about the nursing intervention to be performed as a standard procedure . The nursing intervention was applied. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary for the patients ( Intramuscular , Intravenous , Subcutaneous Injection), that application was applied. No unnecessary procedure was applied.

Other: Control Group (Standard Procedure)

Music Therapy Group

EXPERIMENTAL

Before the application of nursing interventions ( intramuscular , intravenous , subcutaneous injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients were made to listen to Büzürk makam, a Turkish musical makam. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( intramuscular , intravenous , subcutaneous injection), that application was performed on the patients . No unnecessary procedure was performed.

Other: Music Therapy Group

Virtual Reality Group

EXPERIMENTAL

Before the application of nursing interventions ( Intamuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients watched 3D videos with relaxation effect with virtual glasses. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( Intamuscular , Intravenous , Subcutaneous Injection), that application was performed on the patients . No unnecessary procedure was performed.

Other: Virtual Reality Group

Interventions

Control Group (Standard Procedure) OTHER

Before the application of nursing interventions ( Intramuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Then , information was given about the nursing intervention to be performed as a standard procedure . The nursing intervention was applied. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary for the patients ( Intramuscular , Intravenous , Subcutaneous Injection), that application was applied. No unnecessary procedure was applied. .

Control Group (Standard Procedure)

Music Therapy Group OTHER

Before the application of nursing interventions ( intramuscular , intravenous , subcutaneous injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients were made to listen to Büzürk makam, a Turkish musical makam. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( intramuscular , intravenous , subcutaneous injection), that application was performed on the patients . No unnecessary procedure was performed.

Music Therapy Group

Virtual Reality Group OTHER

Before the application of nursing interventions ( Intamuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients watched 3D videos with relaxation effect with virtual glasses. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( Intamuscular , Intravenous , Subcutaneous Injection), that application was performed on the patients . No unnecessary procedure was performed.

Virtual Reality Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients;
• must be over 18 years old,
• have no visual or hearing impairment,
• have stable hemodynamic and physiological parameters (pulse, respiration, blood pressure, oxygen saturation, pain),
• be not intubated,
• be willing to participate in the study.

You may not qualify if:

• Patients;
• have visual and hearing impairment,
• have unstable hemodynamic and physiological parameters (pulse, respiration, blood pressure, oxygen saturation, pain),
• are intubated,
• do not volunteer for the study.

Sponsors & Collaborators

• University of Beykent: lead

Study Sites (1)

Beykent University

Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (3)

• Hamdan KM, Shaheen AM, Abdalrahim MS. Barriers and enablers of intensive care unit nurses' assessment and management of patients' pain. Nurs Crit Care. 2022 Jul;27(4):567-575. doi: 10.1111/nicc.12624. Epub 2021 Apr 1.

  PMID: 33797160 BACKGROUND

• Golino AJ, Leone R, Gollenberg A, Gillam A, Toone K, Samahon Y, Davis TM, Stanger D, Friesen MA, Meadows A. Receptive Music Therapy for Patients Receiving Mechanical Ventilation in the Intensive Care Unit. Am J Crit Care. 2023 Mar 1;32(2):109-115. doi: 10.4037/ajcc2023499.

  PMID: 36854910 RESULT

• Koticha P, Katge F, Shetty S, Patil DP. Effectiveness of Virtual Reality Eyeglasses as a Distraction Aid to Reduce Anxiety among 6-10-year-old Children Undergoing Dental Extraction Procedure. Int J Clin Pediatr Dent. 2019 Jul-Aug;12(4):297-302. doi: 10.5005/jp-journals-10005-1640.

  PMID: 31866714 RESULT

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hamiyet Kızıl, Phd RN

  Istanbul Beykent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD RN Assistant Professor Hamiyet KIZIL

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 21, 2024
• Study Start: May 9, 2022
• Primary Completion: June 9, 2022
• Study Completion: September 9, 2022
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)