Protocol summary

Study aim
Determining the effect of Guided Imagery on anxiety and breast milk volume of mothers of preterm infants
Design
Non-randomized clinical trial with control group, Parallel, Without blinding, On 60 mothers of premature infants
Settings and conduct
After obtaining the consent of the mothers of premature infants admitted to the neonatal intensive care unit of Imam Reza, Ghaem, Umm Al-Banin, Hasheminejad hospitals, the guided imagery technique is performed for the mothers of the intervention group. Mothers in the control group receive routine ward care. Anxiety is measured twice before and after the intervention. Milk volume is measured and recorded four times with a graduated milk glass.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Mother of the baby was born with a fetal age of 28 to 32 weeks 2. The mother has a baby without congenital heart, genetic, gastrointestinal and neurological abnormalities 3. Maternal non-use of psychiatric drugs including: diazepam, oxazepam, alprazolam, chlordiazepoxide 4. The mother has not experienced a traumatic event or stressful event such as the death of a loved one, accident, family quarrels, financial problems in the last 6 months 5. The mother has not previously attended similar relaxation classes or psychotherapy courses Exclusion criteria: 1. Start oral feeding for the baby 2. Lack of cooperation of the mother in doing the exercises
Intervention groups
In the intervention group, the guided imagery technique is performed for one week after training. The mothers in the control group receive routine ward care, including breastfeeding training and how to express milk and breast massage by the ward nurses.
Main outcome variables
Anxiety, Breast Milk Volume

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210324050763N1
Registration date: 2021-06-17, 1400/03/27
Registration timing: registered_while_recruiting

Last update: 2021-06-17, 1400/03/27
Update count: 0
Registration date
2021-06-17, 1400/03/27
Registrant information
Name
Narges Rashid Nooghabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
rashidnn981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Guided Imagery on anxiety and breast milk volume of mothers of preterm infants
Public title
Evaluation of the effectiveness of Guided Imagery on anxiety and breast milk volume of mothers of preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The mother of the baby was born with a fetal age of 28 to 32 weeks The mother has a baby without congenital heart, genetic, gastrointestinal and neurological abnormalities Age over 18 years old mother Maternal non-use of psychiatric drugs including: diazepam, oxazepam, alprazolam, chlordiazepoxide The mother has not experienced a traumatic event or stressful event such as the death of a loved one, accident, family quarrels, financial problems in the last 6 months. The mother has not previously attended similar relaxation classes or psychotherapy courses The mother is not addicted The mother does not take drugs that are contraindicated during breastfeeding, including doxepin tricyclic antidepressants, iodinated compounds, gold salts, salicylates, and anticonvulsants during the intervention. The mother has no history of breast surgery and breast problems (breast fissure, congestion, mastitis and breast abscess) The mother should not take milk-enhancing drugs, including Galactomade and metoclopramide The mother should not have contraindications to breastfeeding such as: galactosemia, mother with active tuberculosis, drug abuse, human immunodeficiency virus, users of certain drugs such as antimetabolites and chemotherapy drugs
Exclusion criteria:
Start oral feeding for the baby Transfer the baby to other centers Infant death Lack of cooperation of the mother in doing the exercises Mother withdraws from further study Use other relaxation methods such as: yoga, meditation, relaxation Illness of the baby (requires mechanical ventilation)
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
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
School of Nursing and Midwifery, Ebne Sina St.
City
MASHHAD
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.009

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

2

Description of health condition studied
Breast Milk Volume
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety
Timepoint
Before intervention, Immediately after intervention
Method of measurement
Spielberger’s State-Trait Anxiety Inventory

2

Description
Breast MilkVolume
Timepoint
Before the intervention, The third day of the intervention 2 hours after the technique, The seventh day of the intervention 2 hours after the technique and one week after the intervention
Method of measurement
Milk volume registration form

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Mothers in the intervention group should do this technique twice a day (9 am and 9 pm) for 15 minutes each time for a week after training. In addition to performing the technique, the mothers of the intervention group benefit from the usual actions of the ward.
Category
N/A

2

Description
Control group: Mothers in the control group receive routine care, including breastfeeding training and how to express milk and breast massage by ward nurses.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Hamid Reza Behnam Vashani
Street address
Ebne Sina Street
City
MASHHAD
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
behnamhr@mums.ac.ir

2

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Hamid Reza Behnam Vashani
Street address
Ahmad Abad Street
City
MASHHAD
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
behnamhr@mums.ac.ir

3

Recruitment center
Name of recruitment center
Ommolbanin Hospital
Full name of responsible person
Hamid Reza Behnam Vashani
Street address
Corner of Ayatollah Behjat 16, Zarrineh Crossroads
City
MASHHAD
Province
Razavi Khorasan
Postal code
91447347667
Phone
+98 51 3223 1061
Email
behnamhr@mums.ac.ir

4

Recruitment center
Name of recruitment center
Hasheminezhad Hospital
Full name of responsible person
Hamid Reza Behnam Vashani
Street address
Moftteh Street, at the end of Abu Reihan Blvd
City
MASHHAD
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3273 7011
Email
behnamhr@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Robab Latifnejad Roodsari
Street address
Ebne Sina Street
City
MASHHAD
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
latifnejadr@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
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
Mashhad University of Medical Sciences
Full name of responsible person
Narges Rashid Nooghabi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebne Sina street
City
MASHHAD
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
rashidnn981@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Narges Rashid Nooghabi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebne Sina Street
City
MASHHAD
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
rashidnn981@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Narges Rashid Nooghabi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebne Sina Street
City
MASHHAD
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
rashidnn981@mums.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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