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Evaluation of Impact of Benson Muscle Relaxation Technique on Pregnancy Nausea&Vomiting Severity.

Protocol summary

Summary
Effects of relaxation on nausea & vomiting has been shown in many studies, but relaxation has not been studied adequately in pregnancy physiologic complications. Due to the important of decreasing in nausea & vomiting of pregnant women, This study evaluates effects of Benson muscle relaxation technique on pregnancy nausea &vomiting severity . IN a quasi – experimental controlled trial and single blind, sixty pregnant women who will be 6-10 weeks of gestation, singleton pregnancy and mild and moderate induced nausea and vomiting of pregnancy and will be excluded the study after three consecutive days leaving the relaxation exercises, will be sampled. First, case group will be followed then, after one month (cleaning period), control group will be followed. On the sampling day, maternal state nausea & vomiting will be measured by using the Pregnancy Unique Quantification Emesis and nausea (PUQE) questionnaire. Interventions will be done for pregnant women in case group as 4 weeks continuously relaxation, session consisted of four identical standardized 10-15 min for two times (morning & afternoon). During interventions, will be asked the mother to again complete the PUQE questionnaire weekly. Interventions will not be done in the control group. During interventions, will be asked them to again complete the PUQE questionnaire weekly. In this study, pregnancy nausea & vomiting severity in two groups will be measured the day before interventions and 4 weeks continuously during interventions by PUQE questionnaire. then results will be compared in groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201307152248N10
Registration date: 2014-02-28, 1392/12/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-28, 1392/12/09
Registrant information
Name
Fereshteh Jahdi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982188773073,00982182471404
Email address
f.jahdi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-08-06, 1392/05/15
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Impact of Benson Muscle Relaxation Technique on Pregnancy Nausea&Vomiting Severity.
Public title
The effect of relaxation on pregnancy nausea
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : singleton pregnancy with a live fetus ; no previous gastrointestinal diseases ; literacy as reading and writing ; ability to use relaxation audio CD ; lack of mental illness known as ; not taking drugs tranquilizers, anti- anxiety, anti- nausea and vomiting are now ; not getting the same period of relaxation ; spontaneous pregnancies ; not suffering spouses to alcohol and drugs and cigarettes ; dislikes stressful experiences in the three months prior to the intervention of relatives , such as the death of relatives ; having a history of bad consequences of pregnancy; 6 to 10 weeks of gestation the pregnancy based on the first day of the last menstrual period or ultrasound ; mild and moderate induced nausea and vomiting of pregnancy and Exclusion criteria:vaginal bleeding or other complications during pregnancy; need for hospitalization during the study; requested requires other therapies; stressful events during the study; use of drug that effects on anxiety during study; need to refer to a psychiatrist during the study; leaving exercises three consecutive days or more.
Age
No age limit
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical commitment of Tehran University of Medical Sciences
Street address
Sixth floor ,Central office, Ghods St, Keshavarz Blvd
City
Tehran
Postal code
19964
Approval date
2013-07-23, 1392/05/01
Ethics committee reference number
306/105/د/92

Health conditions studied

1

Description of health condition studied
Pregnancy nausea and vomiting
ICD-10 code
020-029
ICD-10 code description
Other maternal disorders predominantly related to pregnancy

Primary outcomes

1

Description
Pregnancy nausea and vomiting severity
Timepoint
The day before interventions and 4 weeks continuously during interventions
Method of measurement
By Pregnancy Unique Quantification of Emesis and Nausea (PUQE) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In case group as 4 weeks continuously relaxation, session consisted of four identical standardized 10-15 min for two times (morning & afternoon) will be done.
Category
Prevention

2

Description
Intervention Will not be done in the control group
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Hospital of Tehran University of Medical Sciences
Full name of responsible person
Fereshteh Jahdi
Street address
Midwifery Dep, School of Nursing Midwifery, Tehran University of Medical Sciences, West Nosrat St, Tohid Sq, Tehran.Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sciences vice chancellor for research- Tehran University of Medical Sciences
Street address
Sixth floor ,Central office, Ghods St, Keshavarz Blvd-
City
Tehran, Iran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences, School of Midwifery and Nursing
Full name of responsible person
Fereshteh Jahdi
Position
Master of midwifery
Other areas of specialty/work
Street address
Midwifery dep, School of Nursing Midwifery, Tehran University of Medical Sciences, West Nosrat St, Tohid Sq, Tehran,Iran
City
Tehran
Postal code
4798/19395
Phone
00982188773073,00982182471404
Fax
+98 21 8879 3805
Email
f.jahdi@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences, School of Midwifery and Nursing
Full name of responsible person
Fereshteh Jahdi
Position
Master of midwifery
Other areas of specialty/work
Street address
Midwifery Dep, School of Nursing Midwifery, Tehran University of Medical Sciences, West Nosrat St, Tohid Sq, Tehran,Iran
City
Tehran
Postal code
19395/4795
Phone
+98 21 8247 1404
Fax
+98 21 8879 3805
Email
f.jahdi@iums.ac.ir
Web page address
www.fnm.tums.ac.ir

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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