IRCT | Comparing the effects of music therapy and aromatherapy with lavender on anxiety in mothers of premature infants hospitalized in the neonatal intensive care unit.

Protocol summary

Study aim: Determining the effect of aromatherapy with lavender on the level of anxiety in mothers of premature infants before and after the intervention Determining the effect of music therapy on the level of anxiety in mothers of premature infants before and after the intervention
Design: A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 96 patients. Block randomization will be used for randomization.
Settings and conduct: The present study was conducted on 96 mothers will be allocated in 3 groups.For the aromatherapy group, the illustrated sponge soaked in three drops of lavender essential oil will be used for 1 week (every day of the week).For the music therapy group, 6 30-minute sessions
Participants/Inclusion and exclusion criteria: Inclusion criteria: Primary mothers, Premature infants (less than 37 weeks gestation), Infant hospitalization in NICU, Mother not taking anti-anxiety and sedative medications during the study. Exclusion criteria: Infant discharged earlier than 2 weeks, Mother's sensitivity to the desired scent, Mother's unwillingness to continue participating in the study.
Intervention groups: The present study is a randomized clinical trial of pretest-posttest type that will be conducted on mothers with premature infants referred to the neonatal intensive care unit. The research samples will be selected on a convenience basis and after reviewing the study entry criteria and obtaining written informed consent, they will be randomly assigned to 3 groups. The first group will receive music, the second group will receive aromatherapy with lavender, and the third group will be the control.
Main outcome variables: Independent variable: In this study, music therapy and aromatherapy are the independent variables. Dependent variable: In this study, anxiety of mothers with premature babies is the dependent variable.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20250627066272N1

Registration date: 2025-07-20, 1404/04/29

Registration timing: prospective

Last update: 2025-07-20, 1404/04/29

Update count: 0
Registration date: 2025-07-20, 1404/04/29

Registrant information: Name

Marzieh Dadkhahfar

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 51 3258 7857

Email address

marzidadkhah5402@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2025-08-23, 1404/06/01
Expected recruitment end date: 2025-09-11, 1404/06/20
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparing the effects of music therapy and aromatherapy with lavender on anxiety in mothers of premature infants hospitalized in the neonatal intensive care unit.

Public title: Studying the effect of aromatherapy on anxiety/studying the effect of music therapy on anxiety
Purpose: Supportive
Inclusion/Exclusion criteria: Inclusion criteria:

Primiparous mothers Having a premature baby (gestational age less than 37 weeks), the baby is hospitalized in the neonatal intensive care unit The mother did not take any anti-anxiety or sedative medications during the study.

Exclusion criteria:
Age: No age limit
Gender: Female

Phase

3

Groups that have been masked

Participant

Sample size

Target sample size: 96

Randomization (investigator's opinion)

Randomized

Randomization description

Simple randomization, block

Blinding (investigator's opinion)

Single blinded

Blinding description

Single-blind study The research is conducted at a different location and time, separate from the participants.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee of Mashhad University of Medical Sciences

Street address

Mashhad Mirzakuchakkhan Boulevard, Mirzakuchakkhan 28, Khoshnudi 14, Unit 10

City

Mashhad

Province

Razavi Khorasan

Postal code

9158945348
Approval date: 2025-07-02, 1404/04/11
Ethics committee reference number: IR.MUMS.NURSE.REC.1404.044

Health conditions studied

1

Description of health condition studied: The level of anxiety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: Anxiety score on the Spielberger Questionnaire
Timepoint: Assessing anxiety levels before, during, and after intervention (aromatherapy and music therapy)
Method of measurement: Spielberger Anxiety Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: First intervention group: The aromatherapy group will use a sponge soaked in three drops of lavender essential oil for 1 week (every day of the week), which will be attached to the mothers' clothes with a magnet, and they will be asked to inhale it for 30 minutes.Second intervention group: For the music therapy group, relaxing, wordless music by Erndstein will be played through an MP3 player and headphones for 6 30-minute sessions (every day of the week for 1 week).
Category: Behavior

2

Description: Control group: No intervention will be performed in this group.
Category: Behavior

Recruitment centers

1

Recruitment center: Name of recruitment center

Imam Reza Hospital

Full name of responsible person

Dr. Ezzat Khodashanas

Street address

Mashhad, Ahmadabad, Bahar Street, Imam Reza Hospital

City

Mashhad

Province

Razavi Khorasan

Postal code

9137913316

Phone

+98 51 3852 2826

Email

br8534@bmi.ir

1

Sponsor: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Ms. Dr. Fatemeh Hajiabadi

Street address

Mashhad, Azadi Square, East Gate of Ferdowsi University of Mashhad, Shahid Dr. Kharazmi Educational Complex

City

Mashhad

Province

Razavi Khorasan

Postal code

9177949025

Phone

+98 51 3882 9278

Email

khm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Mashhad University of Medical Sciences
Proportion provided by this source: 90
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Marzieh Dadkhahfar

Position

student

Latest degree

Bachelor

Other areas of specialty/work

Nursery

Street address

Mashhad, Mirzakuchakkhan Boulevard, Mirzakuchakkhan 28, Khashnoudi 14, No. 10, Unit 9

City

Mashhad

Province

Razavi Khorasan

Postal code

9158945348

Phone

+98 51 3258 7857

Email

marzidadkhah5402@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Marzieh Dadkhahfar

Position

student

Latest degree

Bachelor

Other areas of specialty/work

Nursery

Street address

Mashhad, Mirzakuchakkhan Boulevard, Mirzakuchakkhan 28, Khashnoudi 14, No. 10, Unit 9

City

Mashhad

Province

Razavi Khorasan

Postal code

9158945348

Phone

+98 51 3258 7857

Email

marzidadkhah5402@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Marzieh Dadkhahfar

Position

student

Latest degree

Bachelor

Other areas of specialty/work

Nursery

Street address

Mashhad, Mirzakuchakkhan Boulevard, Mirzakuchakkhan 28 Khosnoudi 14, No. 10, Unit 9

City

Mashhad

Province

Razavi Khorasan

Postal code

9158945348

Phone

+98 51 3258 7857

Email

marzidadkhah5402@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: Data can be shared.
When the data will become available and for how long: Access from 1404 until one year after the results are published.
To whom data/document is available: Research Supervisor and Consulting Professor
Under which criteria data/document could be used: Permission to access information for faculty students
From where data/document is obtainable: Go to Mashhad University of Medical Sciences website
What processes are involved for a request to access data/document: Title approval Proposal approval Thesis approval
Comments

Comparing the effects of music therapy and aromatherapy with lavender on anxiety in mothers of premature infants hospitalized in the neonatal intensive care unit.