The main purpose of this study is to determine the effect of consultation and foot reflexology on fatigue on nullparous pregnant women attending health centers in Hamedan. Side goals:
1. Defining the measure of fatigue in pregnant women before and after attending the intervention in 3 main groups.
2. Comparing the average measured fatigue in pregnant women before the intervention in 3 groups.
3. Comparing the average measured in pregnant women after the intervention in 3 groups.
Applicable goals:
Based on this study’s results and if the consultation session is effective on the level of pregnant women’s fatigue, it’s possible to use this economical and non aggressive procedure along side with prenatal care. The current research is based on a randomized study with before and after the intervention. Around 126 pregnant women with the conditions including: 18-35 Years of Age, first and wanted pregnancy, single fetus with the gestational age of 19 to 29 weeks, after the conscious permission and randomized will be divide in 3 groups of control and experimental. In all 3 groups there will be a 30 to 45 minute introduction session on the steps of consultation (GATHER) on the subject of pre-testing. Then the qualified candidates will receive the fatigue measurement questionnaire form. The pregnant women in the first group in addition to the routine pregnancy care will receive consultation for 5 weeks ( 30 minutes per session - 2 times per week). At the beginning of each session, 15 minutes will be allocated to consultation and then the reflexology procedure will be applied for the rest of the session. The pregnant women in the second group in addition to the routine pregnancy care will receive consultation for 5 weeks ( 30 minutes per session - 2 times per week). The pregnant women in the third group( control) will receive the routine pregnancy care. At the end of week 5 all 3 group will fill out the the fatigue measurement questionnaire form. The pregnant women whom due to pregnancy issues including abnormal fetus heart patterns, reduction in feats moment, bleeding, the change in the mental and emotional state, etc whom need medical intervention will be excluded from the study. The reduction of fatigue levels will be considers at the outcome of this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508156888N11
Registration date:2015-10-18, 1394/07/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-18, 1394/07/26
Registrant information
Name
Fatemeh Shobeiri
Name of organization / entity
Hamadan Universiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
shobeiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology and counseling on fatigue in nulliparous pregnant women
Public title
The effect of counseling and foot reflexology on fatigue in women in the first pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: The age range between 18 to 35 years old; First pregnancy and wanted pregnancy; single fetus with the ages of 19 to 29 weeks; not having mental disorders; The absence of the children or disabled spouse. Exclusion criteria: Abnormal fetal heart rate patterns and decreased fetal movements in a way that may require medical intervention; The change in the mental and emotional state
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
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
Research Ethics Committee of Hamadan University of Medical Sciences
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
65178
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
IR.UMSHA.REC.1394.214
Health conditions studied
1
Description of health condition studied
Fatigue
ICD-10 code
o26.8
ICD-10 code description
Exhaustion and fatigue
Primary outcomes
1
Description
Fatigue
Timepoint
Weeks 19-29
Method of measurement
Czech list fatigue assessment
Secondary outcomes
1
Description
Consulting and foot reflexology
Timepoint
Weeks 19-29
Method of measurement
Czech list fatigue assessment
Intervention groups
1
Description
The pregnant women in the first group in addition to the routine pregnancy care will receive consultation for 5 weeks ( 30 minutes per session - 2 times per week). At the beginning of each session, 15 minutes will be allocated to consultation and then the reflexology procedure will be applied for the rest of the session. The reflexology procedure requires the test subject to lay down on a examination bed in a quite and bright room with closed eyes in a relax position. Then after the most foot massage with the left hand hold the heels and with pressure towards the bottom of the feet while rotating the entire foot around the ankle by pressuring the solar plexus with the thumb . This procedure will take around 30 minutes for both feet and then the test subject is required to drink a lot of liquid for 24 to 48 hours after each session.
Category
Other
2
Description
The pregnant women in the second group in addition to the routine pregnancy care will receive consultation for 5 weeks ( 30 minutes per session - 2 times per week).
Category
Other
3
Description
The pregnant women in the third group( control) will receive the routine pregnancy care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Healthcare center Samii 9
Full name of responsible person
Behnaz Manochehri
Street address
Madani settlements
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Bashirian Saeed
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Department of Research and Technology
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178/518
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178/518
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178/518
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)