Effectiveness of foot reflexology on fatigue and anxiety after cesarean section in mothers with hospitalized preterm neonate in Neonatal Intensive Care Unit(NICU)
The purpose of this study is to evaluate the foot reflexology effect (Reflex Zone Therapy) on the fatigue severity and anxiety in mothers with cesarean section and hospitalized preterm neonate in the neonatal intensive care unit (NICU) of Valieasr and jame e zanan Hospitals . In this single blind randomized clinical trial, 99 of mothers who hospitalized at least 3 days in the maternity hospitals will be recruited. The participants with gestational age of 30 to 37 weeks, will be randomly assigned to three groups of reflexology, placebo and control. Data will be collected by questionnair and entered to SPSS Software version 17. Data analysis will be done by descriptive and inferential statistics pre-intervention and post-intervention to evaluate the effectiveness of refleology on reducing fatigue and anxiety of the participants.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203229322N1
Registration date:2012-06-30, 1391/04/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-06-30, 1391/04/10
Registrant information
Name
Elaheh Ruhi rahim begloo
Name of organization / entity
Faculty of Nursing and Midwifery - tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 3600
Email address
e-ruhi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of foot reflexology on fatigue and anxiety after cesarean section in mothers with hospitalized preterm neonate in Neonatal Intensive Care Unit(NICU)
Public title
the effect of foot reflexology massage on fatigue and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Nulliparous mothers with cesarean section and hospitalized for three full days ; mothers with the age of 20-35 years old; mothers should be literate; mothers with no serious physical and psychological disorders; mothers with no tissue damage on their feet; mothers with gestational age of 30-37 weeks; mothers with preterm neonate hospitalized in NICU; the newborns have to be breastfed.
Exclusion criteria: -mothers with no willingness to participate in the trial anymore; mothers with less than three full days hospitalization; mothers who will develop serious health conditions during the trial; mothers who will develop a tissue damage on their feet, during the intervention; mothers who give birth with gestational age of less than 30 weeks; initiating formula feeding in the neonates, for any reasons.
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Nursing and Midwifery- Tehran University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. ,1419733171, Tehran, Iran
City
Tehran
Postal code
1419733171
Approval date
2012-05-24, 1391/03/04
Ethics committee reference number
171/130/د/91
Health conditions studied
1
Description of health condition studied
fatigue
ICD-10 code
F48.8
ICD-10 code description
Other specified neurotic disorders
2
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
anxiety intensity
Timepoint
pre and post intervention (before the initiation of first intervention and after the 3rd day of intervention)
Method of measurement
Spielberger State Anxiety Inventory
2
Description
fatigue intensity
Timepoint
pre and post intervention (before the initiation of first intervention and after the 3rd day of intervention)
Method of measurement
visual analoge scale for fatigue
Secondary outcomes
1
Description
pulse
Timepoint
Once before and once after the third day of intervention and within 10 minutes afte intrventionr
Method of measurement
According to minutes using the standard digital clock
2
Description
blood pressure
Timepoint
Once before and once after the third day of intervention and within 10 minutes after intervention
Method of measurement
Mercury blood pressure devices (Richter)
3
Description
Breathing
Timepoint
Once before and once after the third day of intervention and within 10 minutes afte intrvention
Method of measurement
According to minutes using the standard digital clock
Intervention groups
1
Description
"Foot reflexology massage" or "reflexology" iwill be done for the intervention group which include three stages: preparation, heating with a 15-step techniques and massage techniques on reflex points of the pituitary, spinal cord and solar plexus .reflection of the pituitary is in inner edge of middle portion in the first Knucklebone of the big in plantar plantar, solar plexus is in end of the first metatarsal bone in foot and reflection of the spinal cord is in the inner edge of the foot, starting from the end of the first Knucklebone of the thumb and leads to heel. The total intervention time will be 40 minutes for both legs (20 minutes per foot), within three consecutive days.
Category
Other
2
Description
The intervention in the placebo group includes the preparation and heating with a towel and massage the legs and it is done within three consecutive days and takes 40 minutes for both legs (20 minutes per foot)
Category
Placebo
3
Description
In the control group, no intervention will be applied. This group will only receive routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mirza Koochak khan Hospital
Full name of responsible person
Elaheh Ruhi Rahim Beglou- MS Student in Nursing
Street address
Bimarestane jame e zanan. karimkhane zand st- nejatollahi st, Tehran, Iran.