This study is a clinical trial which will be done in labor ward of Abadan 17 Shahrivar hospital. The study objective is to investigate the effect of acupressure on Hugo point on delivery pain of multiparous women. Study population includes the multiparous women who will give birth vaginally at 17 Shahrivar hospital with a moderate to severe delivery pain in 2 hours after delivery (based on the standard visual pain scale assessment). Inclusion criteria include: Vaginal delivery; second to fourth delivery; gestational age between 37 and 42 weeks; complaint of moderate to severe delivery pain; infant birth weight between 2500 to 4000 gram and body mass index between 18.5 and 29. Exclusion criteria include: Hard and prolonged delivery; addiction; history of cesarean section and intra-abdominal surgery and history of postpartum hemorrhage. Sample size has been calculated as 62 women (31 women in each group). Sampling will be done using blocked randomization sampling with blocks' size of 6. SPPS software (random number generation) will be used for randomization. Also, this study is a single blind trial in which the participants will not inform from their group. To conduct the study, first the delivery pain of women who meet the eligibility criteria of study and have the willingness to participate in the study will be assessed at 2 hours after delivery and those with moderate to severe pain will be randomly allocated to intervention or control group. For intervention group, the delivery pain will be assessed using standard visual pain scale assessment and recorded. Also, pain duration of women will be asked from them and recorded. Then, Hugo point will be pressured by researcher for 4 cycles. Each pressure course will take 20 minutes in which, first the Hugo point will be pressured lightly and the pressure will be increased gradually in such a way that the pressure reaches its maximum within 30 seconds. This maximum pressure will be kept for one minute and then will be reduced so that the pressure will be removed from Hugo point within 30 seconds. This pressure will be repeated for 20 minutes (10 times). Then, the delivery pain again will be assessed and recorded 100 minutes after the termination of the each pressure course, the pain duration also will be asked and recorded in that time and a new pressure course will be started. The pressure courses will be continued up to 8 hours after delivery. In control group, a similar intervention will be done with the exception that an irrelevant point will be pressured rather than Hugo point. Finally, the pain severity and duration of control group, before and after intervention will be compared with those of control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112321670N2
Registration date:2017-01-31, 1395/11/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-31, 1395/11/12
Registrant information
Name
Elham Bahrami
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
bahrami_hmrc@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-01-19, 1395/10/30
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the Effect of acupressure on Hugo point on delivery pain of multiparous women
Public title
The study of the effect of acupressure on Hugo point on delivery pain of multiparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Vaginal delivery; second to fourth pregnancy; gestational age between 37 to 42 weeks; complaint of moderate to severe delivery pain based on the standard visual pain scale assessment; infant birth weight between 2500 to 4000 gram; body mass index between 18.5 to 29
Exclusion criteria: Hard and prolonged delivery; addiction; history of cesarean section and intra-abdominal surgery; history of postpartum hemorrhage
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jondi Shapoor University of Medical Sciences
Street address
Ahvaz Jondi Shapoor University of Medical Sciences, University town, Ahvaz, Iran
City
Ahvaz
Postal code
6135715794
Approval date
2016-10-22, 1395/08/01
Ethics committee reference number
IR.AJUMS.REC.1395.432
Health conditions studied
1
Description of health condition studied
The relationship of acupressure on Hugo point and delivery pain
ICD-10 code
047.1
ICD-10 code description
False labour at or after 37 completed weeks of gestation
Primary outcomes
1
Description
The primary outcome measure of this study is severity of delivery pain.
Timepoint
The severity of delivery pain will be assessed before and after each pressure course.
Method of measurement
Severity of delivery pain will be assessed using standard visual pain scale assessment.
Secondary outcomes
1
Description
Secondary outcome measure of this study is the duration of delivery pain.
Timepoint
Duration of delivery pain will be assessed before and after of each pressure course.
Method of measurement
Duration of delivery pain will be asked from participants and recorded.
Intervention groups
1
Description
Intervention group: For this group, Hugo point will be pressured by researcher for 4 cycles. Each pressure course will take 20 minutes in which, first the Hugo point will be pressured lightly and the pressure will be increased gradually in such a way that the pressure reaches its maximum within 30 seconds. This maximum pressure will be kept for one minute and then will be reduced so that the pressure will be removed from Hugo point within 30 seconds. This pressure will be repeated for 20 minutes (10 times). Then, the delivery pain again will be assessed and recorded 100 minutes after the termination of the each pressure course, the pain duration also will be asked and recorded in that time and a new pressure course will be started. The pressure courses will be continued up to 8 hours after delivery.
Category
Other
2
Description
Control group: In this group, an irrelevant point other than Hugo point will be pressured by researcher for 4 cycles. Each pressure course will take 20 minutes in which, first the Hugo point will be pressured lightly and the pressure will be increased gradually in such a way that the pressure reaches its maximum within 30 seconds. This maximum pressure will be kept for one minute and then will be reduced so that the pressure will be removed from under pressure point within 30 seconds. This pressure will be repeated for 20 minutes (10 times). Then, the delivery pain again will be assessed and recorded 100 minutes after the termination of the each pressure course, the pain duration also will be asked and recorded in that time and a new pressure course will be started. The pressure courses will be continued up to 8 hours after delivery.