NCT05334641

Brief Summary

Introduction: This study has been conducted to determine the effect of music on pain and anxiety levels in patients receiving chemotherapy during COVID-19. Methods: The research has been carried out in a real trial model with adult patients receiving chemotherapy. The sample of the study is consisted of 92 patients (45 in the experimental group and 47 for the control group). The data have been collected by the researcher with Google Forms (using State and Transient Anxiety Inventory and Visual Analog Skala) between March 2020 and July 2020, through the links sent to the phones of participants on the day they received chemotherapy. Results: The mean scores obtained from the post-test STAI (53.11±4.77) and VAS (3.44±2.53) scales in the experimental group have been determined to statistically significantly decrease when compared to the pre-test measurement data (STAI:54.26±4.26; VAS:4.22±2.41) (p\<0.05). No statistically significant difference has been determined between pre-test and post-test mean scores of the patients in the control group. Conclusion: It has been observed that music applications reduce the pain and anxiety levels of patients receiving chemotherapy during the COVID-19 process. It can be recommended to use music applications in the management of pain and anxiety symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

April 17, 2022

Last Update Submit

April 19, 2022

Conditions

Keywords

AnxietyCOVID-19MusicPainPatients receiving chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Google Forms (using State and Transient Anxiety Inventory and Visual Analog Skala)

    The data have been collected by the researcher with Google Forms (using State and Transient Anxiety Inventory and Visual Analog Skala).The posttest was administered 1 hour after the pretest.

    The posttest was administered 1 hour after the pretest.

Study Arms (2)

Experimental Group

EXPERIMENTAL
Other: Listening Music

Control Group

ACTIVE COMPARATOR
Other: Not Listening Music

Interventions

The patients in the experimental group were listened to music.

Experimental Group

The control group was not listened to music.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over the age 18,
  • Being able to communicate,
  • Being literate,
  • Having no diagnosis of psychiatric,
  • Have the necessary technological equipment (phone, internet, etc.)

You may not qualify if:

  • Existing infection
  • Receiving palliative chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vocational School of Health Services

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeoplasmsAnxiety DisordersCOVID-19Pain

Condition Hierarchy (Ancestors)

Mental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rukuye AYLAZ

    Inonu University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 17, 2022

First Posted

April 19, 2022

Study Start

March 3, 2020

Primary Completion

June 29, 2020

Study Completion

June 30, 2020

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations