Protocol summary

Study aim
1-Determining and Comparing the severity of After Pain before the Intervention, Immediately after the Intervention, during 30, 60, and 120 Minutes after the Intervention and 24, 48, and 72 Hours after Delivery in the Verum Reflexology Group 2-Determining and Comparing the Intensity of After Pain before the Intervention, Immediately after the Intervention, during 30, 60, and 120 Minutes after the Intervention and 24, 48, and 72 Hours after Delivery in the Sham Reflexology Group 3- Determining and Comparing the Severity of After Pain at the designated Times, during 30, 60, and 120 Minutes after the designated Times and 24, 48, and 72 Hours after delivery in the Routine Care Group
Design
A clinical trial with a control group, parallel-group, single-strain, randomized, phase II ? on 90 women after childbirth. Excel software is used for randomization.
Settings and conduct
In this study, the research environment will be the postpartum care department of hospital Bent Al-Hoda in Bojnord city and Javadalaimeh in Jajarm city.
Participants/Inclusion and exclusion criteria
log in 1- It should be multipar 2- Natural birth without tools 3- In general, he should not have any lesions or problems in his hands 4- He does not have mental problems and anxiety, he has not used drugs affecting the nervous system Failure to enter 1-Receive less than 2 times real or sham reflexology
Intervention groups
In the real reflexology group, in each hand, first 3 minutes of general massage, then real reflexology is performed Sham reflexology group also performs 3 minutes of general massage on each hand, then Sham reflexology is performed in the form of ineffective pressure. The routine care group receives only routine postpartum care.
Main outcome variables
reducing the intensity of post-partum pain; Reducing the amount of pharmaceutical painkillers after delivery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230710058736N1
Registration date: 2023-10-22, 1402/07/30
Registration timing: prospective

Last update: 2023-10-22, 1402/07/30
Update count: 0
Registration date
2023-10-22, 1402/07/30
Registrant information
Name
Fateme Sahebi mofrad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 582 7685
Email address
safateme19@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Hand Reflexology on Postpartum Pain in Multiparous Women: A Randomized Controlled Clinical Trial Study
Public title
Investigating the Effect of Hand Reflexology on Postpartum pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The Research Unit is willing to Participate in the Study Be Iranian Be 15-45 Years Old Body Mass Index is18/5-29/9 Be Multi-par Be Single Do not have a High-Risk Pregnancy (Pre-Eclampsia, Placental Abnormalities Such as Placental Abruption, Placenta Previa and Placenta Accreta, Chorioamnionitis and Diabetes with Insulin) The Presentation of the Fetus is Cephalic Natural Birth without Tools Do not have Abnormal Bleeding after Delivery The Baby's Weight Should be 2500-4000 Grams Wounds, Burns, Fungal Infections, Warts, Varicose veins, Thickening of Skin Layers, often Yellow in Color, Numbness, and in General, do not have any Lesions or Problems in the Hands Don't have Contagious Skin Disease on Hands such as Scabies, Chicken Pox, Jaundice He doesn't have Mental Problems and Anxiety, he doesn't use Drugs that Affect the Nervous System The Mother should not be Prohibited from Breastfeeding The Intensity of the Back Pain should be Mild to Severe According to the Numerical Rating Scale of Pain The Placenta and Membranes have not been Removed by Hand (Uterine Courage).
Exclusion criteria:
The Research Unit does not want to Continue Participating in the Research Received Additional Treatments to Control Postpartum Bleeding (such as Oxytocin, Methylergonovine, Prostaglandin E1, Prostaglandin f2α, Blood Transfusion, Surgery) Uterine Curettage has been Performed During the Study The Mother is unable to Continue Breastfeeding Receive less than 2 Times Verum or sham reflexology
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
It is accessible (simple) and goal-oriented. All patients who meet the conditions for entering the study are examined. Random Allocation of Samples will be done using Excel Software. Finally, People will be divided into 3 Groups: Verum Intervention (30 people), Sham Intervention (30 people) and Routine Care (30 people).
Blinding (investigator's opinion)
Single blinded
Blinding description
The Research Unit will be Randomly assigned to 3 Groups: Verum Intervention, Sham Intervention and Routine Care Using Excel Software. The Verum and Sham Intervention Groups will be Fully Explained about the Objectives of the Research and not only about the Existence of the Routine Care Group, but also about the Fact that they may be Randomly Placed in one of the Two Verum Intervention Groups. The Sham Intervention is Similar to the Verum Intervention in every way, Including the Place, Time, Technique and Frequency of the Intervention, and the only Difference is in the Amount of Pressure Applied and thus Blinding. It is done because they do not know Exactly the Type of Intervention. One of the Limitations of the Research is the Detailed Explanation of the Objectives of the Research to the Routine Care Group. The Explanation to this Group is that the Study will be conducted with the Aim of Investigating the Severity of Postpartum Pain, and it is tried to Separate the Room of the Routine Care Group from the other Two Groups. Also, the Clinical Caregivers (Nurses and Midwives of the Post-Partum Department) and Gynecologists of the Center know about the Objectives of the Research, but they do not know the Type of Intervention Received by each Research Unit, in Fact, they do not know which Intervention each Person received.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Pharmacy and Midwifery Nursing, Shahid Beheshti University of Medical
Street address
Block A, 13th floor, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran Street, between South Flamak and Zarafshan, Quds Town (West), Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-10-11, 1402/07/19
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.118

Health conditions studied

1

Description of health condition studied
Postpartum uterine pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Postpartum pain
Timepoint
Within 2 hours before the intervention, immediately after the intervention, within 30, 60, and 120 minutes after the intervention and 24, 48, and 72 hours after delivery.
Method of measurement
Numerical rating scale is a tool to measure the intensity of pain, which is in the form of a 10 cm ruler with 11 numbers.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Verum reflexology group in each hand, first, 3 minutes of massage, then the real reflection of the thumb and the researcher reflects the pressure snake in the heart reflection and the solar network and pressure with the Mole technique in the pituitary and uterine reflexion area, the pressure rate in the reflection areas is so high that the research unit does not feel pain and not in the third third of the thumb. The reflection time in each refrigerator area is 2 minutes, and in the past 9 minutes of intervention time for the right hand (the heart reflection area only in the left hand) and 11 minutes of intervention time for the left hand
Category
Treatment - Other

2

Description
Intervention group: Sham reflexology group in each hand, first, 3 minutes of massage, then the reflection of the shaped by the thumb and the researcher referring, the pressure of the snake in the reflective and distribution of the solar and the solar network, and the high-end system with the Mole technique in the pituitary and uterine reflexent region, the rate of pressure in reflective areas is so high that it does not create a color in the upper third thumb. The duration of the reflection of the sham in each refrigerator area is 2 minutes, and in the past 9 minutes of intervention time for the right hand (the heart reflection area only in the left hand) and 11 minutes of intervention time for the left hand
Category
Placebo

3

Description
Control group: The routine care group receives only routine care after delivery
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Bent Al-Hoda Hospital
Full name of responsible person
fateme sahebi mofrad
Street address
Western Taleghani St, Zaishgah Crossroads, Honar St, Bent Al Hoda Hospital
City
bojnourd
Province
North Khorasan
Postal code
9414951156
Phone
+98 58 3223 6551
Email
info@nkums.ac.ir

2

Recruitment center
Name of recruitment center
Javad Alaemeh Hospital
Full name of responsible person
fateme sahebi mofrad
Street address
Imam Reza Blvd
City
jajarm
Province
North Khorasan
Postal code
9441656574
Phone
+98 58 3227 6001
Email
info@nkums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Chamran Highway, Yemen St, Parvaneh St, Building No. 2 of Shahid Beheshti University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Sahebi mofrad
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Tehran, intersection of Ayatollah Hashemi Rafsanjani highway and Wali Asr street, Niayesh campus in front of Shahid Rajaei heart hospital, Faculty of Nursing and Midwifery
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
Email
safateme19@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Sahebi mofrad
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Tehran, intersection of Ayatollah Hashemi Rafsanjani highway and Wali Asr street, Niayesh campus in front of Shahid Rajaei heart hospital, Faculty of Nursing and Midwifery
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
Email
safateme19@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Sahebi mofrad
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 9-7, Aref Jajarmi Ave., Poya Blvd
City
Jajarm
Province
North Khorasan
Postal code
9441913359
Phone
+98 915 582 7685
Fax
Email
safateme19@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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