The effect of spiritual care based on "Ghalb Salim" model on maternal anxiety and physiological parameters of preterm infants hospitalized in neonatal intensive care units of hospitals affiliated to Shiraz University of Medical Sciences
1) Objective: Determining the effect of spiritual care based on "Ghalb Salim" model on maternal anxiety and physiological parameters of preterm infants hospitalized in neonatal intensive care units 2) Design: randomized clinical trial 3) Setting and action: total of 60 mothers with preterm infant enrolled in the study through convenience sampling method from hospitals that will be randomly divided into two experimental and control groups. The mothers in the experimental group will receive spiritual care during 4 sessions and each session 30 minutes, and after each session will perform kangaroo care for their infants. The mothers in the control group will perform kangaroo care for their infants during 4 sessions without any spiritual care. Mother's anxiety level will be measured by the Speilberger anxiety inventory before and after intervention, and infants heart rate, respiratory rate and blood oxygen saturation 10 minutes before, during and 10 minutes after kangaroo care will be measured. Finally, the changes in the anxiety score and the physiological parameters of the two groups will be compared. 4) Major inclusion criteria: No history of preterm infant hospitalization in previous pregnancies; having a neonate at the gestational age of 28-36 weeks; neonate with postnatal age of 3-5 days; and absence of any congenital abnormality in neonate. Major exclusion criteria: Mother's unwillingness to continue cooperation; neonatal death; and physical manifestation of any illness in neonate during the study. 5) Interventions: Spiritual care in the experimental group, anxiety assessment of the mothers using the Speilberger anxiety inventory before and after the intervention, recording the physiological parameters of the neonate before, during and after the kangaroo care. 6) Main outcome measures (variables): Heart rate, respiratory rate, and blood oxygen saturation of the neonate and mother's anxiety.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041333410N1
Registration date:2017-08-13, 1396/05/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-13, 1396/05/22
Registrant information
Name
Zaynab Noeizad
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
noeizad@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual care based on "Ghalb Salim" model on maternal anxiety and physiological parameters of preterm infants hospitalized in neonatal intensive care units of hospitals affiliated to Shiraz University of Medical Sciences
Public title
The effect of spiritual care on maternal anxiety and physiological parameters of preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Being Muslim; having primary school education (minimum); Persian speaking; not having known mental illness based on mother's statements; non-use of antidepressant drug or narcotics based on mother's statements; no history of preterm infant hospitalization in previous pregnancies; not being exposed to any other stressful event in the last 6 months; confirmation of the mother's ability to perform kangaroo care by their physician; having a neonate with a gestational age of at least 28th week to the end of the 36th week; neonate with postnatal age of 3-5 days; absence of any congenital abnormality in neonate; single preterm infant. Exclusion Criteria: Mother's unwillingness to continue cooperation; neonatal death; physical manifestation of any illness in neonate during the study; neonatal need for ventilator during the study.
Age
From 3 days old to 5 days old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Study in two hospitals will be done in two steps. To do the first turn, by lottery method, hospitals were divided into two control and experimental groups. In the second turn, the control and experimental group will change.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Postal code
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
IR.SUMS.REC.1396.72
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
2
Description of health condition studied
preterm infant
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
Heart rate
Timepoint
10 minutes before, during and 10 minutes after kangaroo care
Method of measurement
Pulse oximetry
2
Description
mothers anxiety
Timepoint
Before the intervention, after the end of the intervention
Method of measurement
speilberger anxiety questionnaire
3
Description
Respiration rate
Timepoint
10 minutes before, during and 10 minutes after kangaroo care
Method of measurement
Observation
4
Description
Blood oxygen saturation
Timepoint
10 minutes before, during and 10 minutes after kangaroo care
Method of measurement
Pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, mothers receive the spiritual care education based on "Ghalb Salim" model in 4 sessions individually. The duration of each session will be 30 minutes.
Category
Other
2
Description
In the control group, no intervention will be performed.