Background and Objectives: Infertility is one of the main stressful events of life and a crisis affecting various dimensions of infertile couples’ lives. Relaxation, as a strategy, can be effective in the individuals’ resistance to stress and anxiety. Therefore, the present study aimed to assess the effect of relaxation on mother’s anxiety and maternal-fetal attachment in primiparous women who used In Vitro Fertilization (IVF) to get pregnant.
Methods: In this clinical trial, 80 primiparous women who had used IVF to get pregnant were randomly divided into a control and an intervention group. The intervention group took part in four 90-minute relaxation classes in addition to receiving the routine pregnancy care. Anxiety and maternal-fetal attachment were evaluated before and one month after the intervention. Also, maternal-infantile attachment score was computed after delivery.
Results: The results revealed no significant difference between the two groups regarding the mean scores of anxiety and attachment before the intervention. However, a significant difference was observed in this regard after the intervention.
Conclusion: The study results showed that relaxation training was effective in reduction of anxiety and increase of maternal-fetal attachment in the women who had used IVF to get pregnant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109097497N2
Registration date:2014-05-19, 1393/02/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-19, 1393/02/29
Registrant information
Name
Monireh Tousi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3832 0151
Email address
toosim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz Univercity of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of relaxation on mother’s anxiety and maternal-fetal attachment in primiparous women with IVF
Public title
The effect of relaxation on mother’s anxiety and maternal-fetal attachment
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria of the study were being primiparous; having used IVF to get pregnant; being 18-40 years old; having at least middle school degree; gestational age of 32-35 weeks; not having obstetric problems; and singleton pregnancy.
On the other hand, the exclusion criteria of the study were suffering from cardiovascular diseases or serious psychological disorders and having pregnancy complications such as bleeding; diabetes; hypertension; and preterm labor
Age
From 40 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
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
Shiraz University of Medical Sciences, Shiraz, Iran
Street address
Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz,
Postal code
7176815674
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
90-01-42-42-84
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F40-F48
ICD-10 code description
Neurotic, stress-related and somatoform disorders
Primary outcomes
1
Description
Anxiety
Timepoint
Befor intervention and one month after intervention
Method of measurement
Spielberger's scale
Secondary outcomes
1
Description
Maternal-infantile attachment
Timepoint
Befor and one month after intervention
Method of measurement
Cranly's questionnaire
Intervention groups
1
Description
Then, the mothers in the intervention group were divided into two 20-subject groups and participated in four 90-minute educational classes weekly held on Saturdays. It should be mentioned that the intervention group received relaxation training in addition to the routine pregnancy care. The intervention was performed as follows:
First session: anatomical, physiological, and hormonal changes during pregnancy, sperm and ovum, stages of IVF, physiology of fetal development, signs of anxiety, effects of anxiety on pregnancy, strategies for more adaptation with changes in pregnancy including appropriate nutrition, individual health, physical health, mental health, identification of methods for improving compatibility with changes in pregnancy such as relaxation, and effects of relaxation.
Second session: development of fetus in different months of pregnancy, nutrition during pregnancy, effect of healthy nutrition and pregnancy care on maternal and fetal health, effect of relaxation on reduction of anxiety, and effect of relaxation on mother and fetus' physical and mental health.
Third session: Signs of risk in pregnancy and ways to cope with them, and effect of relaxation on improvement of mother's sleeping and nutrition, maternal-fetal attachment, and fetal growth.
Fourth session: effect of relaxation on delivery process, necessity to perform relaxation during delivery, effect of relaxation on improvement after delivery, breastfeeding, and reduction of postpartum depression.
At the end of all the educational sessions, Benson's relaxation technique was performed. This technique is quite easy and safe and the mothers were reassured regarding its safety by a gynecologist. This method is very easy to learn and does not take more than 10-20 minutes to perform (from the tip of toes to forehead). Benson's relaxation technique can be done while lying down or sitting on the chair. In order to make sure that women did the relaxation technique at home, in addition to an educational CD, they were provided with a checklist to record their daily exercises. The mothers were required to perform the relaxation technique at least once a day. At the beginning of each educational session, the checklists were collected, the educational content of the previous session was reviewed, and the participants' questions were answered. The most important practical trainings included staying in a calm environment, mental preparation, passive attitude, staying in a comfortable status, relaxation of all body muscles from the sole of the foot towards the upper extremities (for 10-20 minutes), and slowly getting out of relaxation.
Category
Behavior
2
Description
The control group only received the routine care
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Marzieh Akbarzadeh
Street address
Shiraz- College of midwifery
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
MarzehAkbarzadeh
Street address
Fatemeh School of Nursing and Midwifery, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences - Shiraz, Iran
Full name of responsible person
Akbarzadeh Marzieh
Position
MSC
Other areas of specialty/work
Street address
Fatemeh School of Nursing and Midwifery- Shiraz
City
shiraz
Postal code
Phone
+7 1164744257
Fax
Email
akbarzadehmarzieh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemeh School of Nursing and Midwifery- Shiraz
Full name of responsible person
Marzieh Akbarzadeh
Position
Msc
Other areas of specialty/work
Street address
Fatemeh School of Nursing and Midwifery-Shiraz
City
Shiraz
Postal code
Phone
+7 1164744257
Fax
Email
Akbarzadehmarzieh @yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Monireh toosi
Position
MSc.
Other areas of specialty/work
Street address
Fatemeh School of Nursing and Midwifery- Shiraz
City
shiraz
Postal code
Phone
00
Fax
Email
toosim_m@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)