Two-arm parallel intervention and comparison groups with non-blinded trial
Settings and conduct
This is an open-label trial study. It will be conducted at 4 maternity clinics. The participants will be divided into intervention and control groups based on the maternity clinic randomly.
Participants/Inclusion and exclusion criteria
The inclusion criteria of pregnant women are:
a. Primigravida or Gravida 0 (Nulliparous)
b. at 37-42 weeks of gestation.
c. age between 20 and 35 years.
d. having a singleton and cephalic presentation.
e. agree to participate in the study;
The exclusion criteria of pregnant women who are having:
a. severe pre-eclampsia.
b. unstable hemodynamic.
c. physiatric disorder.
d. comorbidities (cardiovascular, nephrology, neurology, hematology, musculoskeletal disorder) diagnosed by doctor during pregnancy.
e. contraindicated for normal delivery.
f. contraindicated for Shiatsu massages such as varicose veins, wounds, fractures, new scars, and areas of inflammation
Intervention groups
Shiatsu massage is the method of intervention in this study.
Group 1: intervention group will be given a shiatsu massage.
Step 1: The massage will be given at the sacral point for a 3-second rotary pressing motion.
Step 2: one thumb will be placed on top of the other thumb and pressed for 3 seconds at each pressing point
Step 3: the mother's hand is wrapped around the working hand to provide support. The mother will be represented by the thumb and fingers. and press for 3 seconds at each pressing point
Step 4: The second knuckle index finger is placed at the highest holy point, and then with the massager body weight, the knuckle will be rotated in a straight line down the sacrum.
Control group: usual care of pregnant women during labor
Main outcome variables
Pain score,
Anxiety score,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220317054316N1
Registration date:2022-03-31, 1401/01/11
Registration timing:registered_while_recruiting
Last update:2022-03-31, 1401/01/11
Update count:0
Registration date
2022-03-31, 1401/01/11
Registrant information
Name
ISA MOHAMAD-RODI
Name of organization / entity
Universiti Teknologi MARA
Country
Malaysia
Phone
+60 19-345 3515
Email address
rodi@uitm.edu.my
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-01, 1400/10/11
Expected recruitment end date
2022-06-30, 1401/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EXPLORING ROLE OF SHIATSU MASSAGE AS A PAIN RELIEF IN LABOUR
Public title
The Impact of Shiatsu Massage as a Pain Relief in Labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Primigravida or Gravida 0 (Nulliparous)
at 37-42 weeks of gestation,
age between 20 and 35 years
having a singleton and cephalic presentation
agree to participate in the study
Exclusion criteria:
severe pre-eclampsia
unstable hemodynamic
physiatric disorder
comorbidities (cardiovascular, nephrology, neurology, hematology, musculoskeletal disorder) diagnosed by doctor during pregnancy
contraindicated for normal delivery
contraindicated for Shiatsu massage such as varicose veins, wounds, fractures, new scars, and areas of inflammation
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:
80
Randomization (investigator's opinion)
Not 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
Health Research Ethic Committe. Health Polytechnic of Ministry of health East Kalimantan
Street address
Jl. W. Monginsidi No.38, Sidodadi, Kec. Samarinda Ulu, Kota Samarinda, Kalimantan Timur 75243, Indonesia
City
Samarinda
Postal code
75243
Approval date
2022-03-28, 1401/01/08
Ethics committee reference number
LB.01.01/7.1/001509/2022
Health conditions studied
1
Description of health condition studied
pregnant women without any co-morbidities
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain score
Timepoint
T0: Baseline (at the latent phase (1 - 3 cm opening of the Os), T1: 30 minutes after intervention done at the latent phase), T2: 30 minutes after intervention given at the active (4 – 7 cm opening of the os) and transition phases (8 – 9 cm opening of the os)
Method of measurement
Numeric pain rating scales (NPRS)
2
Description
anxiety score
Timepoint
T0: Baseline (at the latent phase (1 - 3 cm opening of the Os), T1: 30 minutes after intervention done at the latent phase), T2: 30 minutes after intervention given at the active (4 – 7 cm opening of the os) and transition phases (8 – 9 cm opening of the os)
Method of measurement
Hamilton Anxiety Rating Scale (HARS)
Secondary outcomes
1
Description
qualitative assessment of the experience of applying shiatsu massages duirng labor
Timepoint
after deliver the baby
Method of measurement
phenomenology study using Question Plotting. Only tape recorder will be used in this section
Intervention groups
1
Description
Intervention group (Group 1): Receive Shiatsu massages. Shiatsu massage is the method of intervention in this study. Group 1: intervention group will be given a shiatsu massage. Step 1: The massage will be given at the sacral point for a 3-second rotary pressing motion. Step 2: one thumb will be placed on top of the other thumb and pressed for 3 seconds at each pressing point Step 3: the mother's hand is wrapped around the working hand to provide support. The mother will be represented by the thumb and fingers. and press for 3 seconds at each pressing point Step 4: The second knuckle index finger is placed at the highest holy point, and then with the massager body weight, the knuckle will be rotated in a straight line down the sacrum.
Category
Treatment - Other
2
Description
Control group (Group 2): The pregnant women only receive usual care during pregnancy at labor.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The Ramlah Parjib Maternity Clinic
Full name of responsible person
Hestri Norhafipah
Street address
Jl. Kadrie Oening Gang Monalisa No.77, Air Hitam, Kec. Samarinda Ulu, Kota Samarinda, Kalimantan Timur 75243, Indonesia
City
Samarinda
Postal code
75243
Phone
+62 812-5815-2918
Email
hestrinorhapifah@itkeswhs.ac.id
2
Recruitment center
Name of recruitment center
The Kartika Jaya Maternity Clinic
Full name of responsible person
Hestri Norhafipah
Street address
Jl. Merdeka 3 No.014, RT.088, Sungai Pinang Dalam, Kec. Sungai Pinang, Kota Samarinda, Kalimantan Timur 75117, Indonesia
City
Samarinda
Postal code
75117
Phone
+62 812-5815-2918
Email
hestrinorhapifah@itkeswhs.ac.id
3
Recruitment center
Name of recruitment center
The Aminah Amin Rianta Maternity Clinic
Full name of responsible person
Hestri Norhafipah
Street address
Jl. Merdeka 1, Sungai Pinang Dalam, Kec. Samarinda Utara, Kota Samarinda, Kalimantan Timur 75117, Indonesia
City
Samarinda
Postal code
75117
Phone
+62 812-5815-2918
Email
hestrinorhapifah@itkeswhs.ac.id
4
Recruitment center
Name of recruitment center
The Ayu Husada Maternity Clinic
Full name of responsible person
Hestri Norhafipah
Street address
Jalan Poros Samarinda Anggana, Sambutan, Kec. Sambutan, Kota Samarinda, Kalimantan Timur 75115, Indonesia
City
Samarinda
Postal code
75115
Phone
+62 812-5815-2918
Email
hestrinorhapifah@itkeswhs.ac.id
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yayasan Wiyata Husada Samarinda
Full name of responsible person
Mujito Hadi
Street address
Jl. Kadrie Oning Gg Monalisa, No 77 Samarinda
City
Samarinda
Postal code
75243
Phone
+62 821-4829-2967
Email
hestrinorhapifah@itkeswhs.ac.id
Grant name
Yayasan Wiyata Husada Samarinda
Grant code / Reference number
0096/Con/II.a/YWHS/XII/2020
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yayasan Wiyata Husada Samarinda
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
institut teknologi kesehatan wiyata husada samarinda
Full name of responsible person
Hestri Norhafipah
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jl. Kadrie Oening Gang Monalisa No.77, Air Hitam, Kec. Samarinda Ulu, Kota Samarinda, Kalimantan Timur 75243, Indonesia
City
Samarinda
Province
East Kalimantan
Postal code
75243
Phone
+62 812-5815-2918
Email
hestrinorhapifah@itkeswhs.ac.id
Person responsible for scientific inquiries
Contact
Name of organization / entity
institut teknologi kesehatan wiyata husada samarinda
Full name of responsible person
Hestri Norhapifah
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jl. Kadrie Oening Gang Monalisa No.77, Air Hitam, Kec. Samarinda Ulu, Kota Samarinda, Kalimantan Timur 75243, Indonesia
City
Samarinda
Province
East Kalimantan
Postal code
75243
Phone
+62 812-5815-2918
Email
hestrinorhapifah@itkeswhs.ac.id
Person responsible for updating data
Contact
Name of organization / entity
institut teknologi kesehatan wiyata husada samarinda
Full name of responsible person
Hestri Norhapifah
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jl. Kadrie Oening Gang Monalisa No.77, Air Hitam, Kec. Samarinda Ulu, Kota Samarinda, Kalimantan Timur 75243, Indonesia
City
Samarinda
Province
East Kalimantan
Postal code
75243
Phone
+62 812-5815-2918
Email
hestrinorhapifah@itkeswhs.ac.id
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Exploring the Role of a Shiatsu Massage as a Pain Relief in Labor.
All collected deidentified IPD. IPD will be collected for the primary and secondary outcomes only.
When the data will become available and for how long
Starting 1st July 2022
To whom data/document is available
This is only available for researchers and researchers' institutions.
Under which criteria data/document could be used
Data will be kept confidential by the principal investigator and can only be shared by the team members. Data will be analyzed using statistical software. Any access to the data must obtain permission from all team members.
From where data/document is obtainable
data will be collected from pregnant women in labor. Data will be kept confidential by the principal investigator. Any permission needs to contact the principal investigator.
What processes are involved for a request to access data/document
Any information about the data needs to contact the principal investigator for permission.