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The effect of aromatherapy and orientation tour on anxiety, stress, and depressed mood in mothers of preterm infants

Protocol summary

Study aim
Comparison of aromatherapy and orientation tour on anxiety, stress and depressed mood in mothers of preterm infants
Design
This study is a semi-experimental, single-blind, three-group trial (two intervention groups and one control group - 42 participants in each group). Continuous sampling will be performed in mothers of pre-term infants who will be admitted to the neonatal intensive care unit (NICU) of Shahid Akbarabadi Hospital. Sampling will be carried out at the beginning of each week by selecting one of the three cards marked Nos. 1 to 3.
Settings and conduct
Orientation tour group: At first, four drops of distilled water, as a placebo, will be dripped on a pad and attached to the mother’s collar of clothes. The mother will typically inhale it for 30 minutes. Then the mother and the researcher will enter into the NICU for the first time. The mother will familiarize with the NICU by brief and understandable explanations about equipment, personnel, rules of the NICU for 30 minutes. The mothers of this group will re-inhale pad, which drips with four drops of distilled water for 30 minutes before bedtime. Aromatherapy and orientation tour group: All steps are similar to the orientation tour group, but instead of using distilled water, four drops of 2% orange essence on a pad, will be inhaled. Control group: The control group will meet their baby for the first time in the usual way, and all schedules for completing the questionnaires for this group will be included.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranian primiparous women, gestational age of 30 - 36 weeks; Exclusion criteria: a history of recurrent miscarriage or infertility, mental illness
Intervention groups
Orientation tour; Aromatherapy and orientation tour
Main outcome variables
State anxiety, trait anxiety, stress, depressed mood

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090810002324N16
Registration date: 2020-06-06, 1399/03/17
Registration timing: prospective

Last update: 2020-06-06, 1399/03/17
Update count: 0
Registration date
2020-06-06, 1399/03/17
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1813
Email address
keshavarz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-31, 1399/05/10
Expected recruitment end date
2021-01-29, 1399/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy and orientation tour on anxiety, stress, and depressed mood in mothers of preterm infants
Public title
Aromatherapy and orientation tour on anxiety, stress and depressed mood
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian primiparous women Single Pregnancy Pregnancy age 30 - 36 weeks First entry into the neonatal intensive care unit Ability to at least read and write Respiratory distress in the newborn
Exclusion criteria:
Substance-abusing (cigarettes, alcohol, and psychotropics) The problem of smell, respiratory diseases, sensitivity to the orange aroma Use of herbal oils and sedatives at least six weeks before the intervention Mental illness (according to the personal reporting) History of recurrent miscarriage or infertility Congenital anomaly in newborn The referred newborn from other hospitals Apgar score of 6 or less at minutes 5
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
All questionnaires at all stages, will be gathered by the research assistant who is unaware of the groups' allocation.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Iran University of Medical sciences
Street address
Iran University of Medical Sciences, Milad Tower, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-05-27, 1399/03/07
Ethics committee reference number
IR.IUMS.REC.1399.241

Health conditions studied

1

Description of health condition studied
The state and trait anxiety, stress, depressed mood
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The score of state anxiety
Timepoint
One hour before the mother's first visit to the neonatal intensive care unit (NICU), an hour after leaving the ward, Twenty-four hours after the intervention
Method of measurement
The state anxiety of Spielberger questionnaire

2

Description
The score of trait anxiety
Timepoint
One hour before the mother's first visit to the NICU, an hour after leaving the ward, Twenty-four hours after the intervention
Method of measurement
The trait anxiety of Spielberger questionnaire

3

Description
The score of parental stress
Timepoint
Twenty-four hours after the intervention
Method of measurement
The Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)

4

Description
The score of depressed mood in the Profile of Mood States Questionnaire (POMS) (McNair)
Timepoint
One hour before the mother's first visit to the NICU, twenty-four hours after the intervention
Method of measurement
Depressed mood in the Profile of Mood States Questionnaire (POMS) (McNair)

Secondary outcomes

empty

Intervention groups

1

Description
Orientation tour: At first, four drops of distilled water, as a placebo, will be dripped on a pad and attached to the mother’s collar of clothes. The mother will inhale it normally for 30 minutes. After removing the pad, the mother and the researcher will enter into the neonatal intensive care unit (NICU) for the first time. Then the orientation tour will be individually held for the mother in a 30- minute section. The mother will be familiarized with the NICU by brief and understandable explanations about equipment such as ventilator, incubator, phototherapy set, pulse oximeter, monitor, warmer and other devices. Employees will be introduced and rules in the NICU will also be explained. At the end of intervention’s day, the mothers of this group will re-inhale pad which drips with four drops of distilled water, for 30 minutes before bedtime.
Category
Prevention

2

Description
Aromatherapy and Orientation tour: At first, four drops of 2% orange essence (made by the Barij Essence Pharmaceutical Company) will be dripped on a pad and attached to the mother’s collar of clothes. The mother will inhale it normally for 30 minutes. After removing the pad, the mother and the researcher will enter into the neonatal intensive care unit (NICU) for the first time. Then the orientation tour will be individually held for the mother in a 30- minute section. The mother will be familiarized with the NICU by brief and understandable explanations about equipment such as ventilator, incubator, phototherapy set, pulse oximeter, monitor, warmer and other devices. Employees will be introduced and rules in the NICU will also be explained. At the end of intervention’s day, the mothers of this group will re-inhale pad, which drips with four drops of 2% orange essence, for 30 minutes before bedtime.
Category
Prevention

3

Description
Control group: The control group will meet their baby for the first time in the usual way, and all schedules for completing the questionnaires in this group will be included. None of the aromatherapy and orientation tour methods will be performed for this group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Akbar-abadi Hospital
Full name of responsible person
Arash Bordbar
Street address
Mowlavi st, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazeme Malakouti
Street address
Iran University of Medical Sciences, Milad Tower, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
vcm@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
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
Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1813
Email
Keshavarz.m@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1813
Email
keshavarz.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elham Babaee
Position
Midwife who is working at Shahid Akbar Abadi Hospital
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Moulavi st, Tehran
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
babaei.e@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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