1. Home
  2. Approved trials
  3. » فارسی

The effect of topical ointment of Propolis on severity of episiotomy pain and wound healing: a randomized controlled trial

Protocol summary

Study aim
Determining the effect of propolis on severity of episiotomy pain and wound healing
Design
A three-blind controlled randomized controlled clinical trial, 72 women with 1 and 2 pregnancies will be assigned to one of the intervention and control groups with a ratio of 1:1, using a purpose-based sampling method.
Settings and conduct
People will be selected from Alzahra and Taleghani hospitals. Stratification will be done based on first and second birth. Ointments of both groups will be completely similar in appearance. In addition to the person determining the sequence of placement of people in the groups, the only person who will know the type of drug prescribed will be the research assistant, and the participants, researcher, data collectors and analysts will not be informed.
Participants/Inclusion and exclusion criteria
Entry requirements: gravid one and two, living in Tabriz city, willingness and possibility of mother's referral to Alzahra and Taleghani hospitals on the 10th day and vaginal delivery with mediolateral incision; Conditions of non-entry: prolonged rupture of the amniotic sac, certain drugs using, alcohol or drug addiction, history of diseases interfering with wound healing, abnormal postpartum bleeding, preterm labor, allergy to Propolis, large or extended episiotomy, history of surgery or visible lesions in the perineum, severe anemia, other tears besides episiotomy, non-continuance of cooperation, incomplete participation
Intervention groups
The intervention group will use 2 centimeter of Propolis ointment 2 times a day with an interval of 12 hours and the control group will use placebo ointment 2 times a day with an interval of 12 hours for a length of 2 centimeter for 10 days.
Main outcome variables
Pain level and wound healing of episiotomy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110524006582N37
Registration date: 2023-03-09, 1401/12/18
Registration timing: prospective

Last update: 2023-03-09, 1401/12/18
Update count: 0
Registration date
2023-03-09, 1401/12/18
Registrant information
Name
Mahin Kamalifard
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 414796770
Email address
kamalifardm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-13, 1401/12/22
Expected recruitment end date
2024-03-12, 1402/12/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical ointment of Propolis on severity of episiotomy pain and wound healing: a randomized controlled trial
Public title
The effect of topical ointment of Propolis on severity of episiotomy pain and wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gravid one and two women Living in Tabriz city Willingness and possibility of the mother to go to Alzahra and Taleghani hospitals on the 10th day Vaginal delivery with mediolateral incision
Exclusion criteria:
Prolonged rupture of the amniotic sac (more than 18 hours) Use of special drugs such as anti-inflammatory and anticoagulant drugs Addiction to alcohol or drugs History of diseases interfering with wound healing such as systemic, cardiac, renal, pulmonary diseases, coagulation disorder, immunodeficiency, connective tissue disorder, diabetes, anemia, mental illness, hemophilia (based on medical records) Abnormal postpartum bleeding Preterm labor Allergy to propolis Large or extended episiotomy (third or fourth degree tear and episiotomy cut length greater than 3-4 cm) History of surgery or visible lesions in the perineum Severe anemia (hemoglobin less than 7 grams per deciliter) Other tears in addition to episiotomy, such as urethral tears Non-continuing cooperation of participants Incomplete participation that is not possible to achieve results
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done based on the purpose, the sequence of allocation in the intervention groups will be using a computer randomization program and with an allocation ratio of 1:1. In order to hide the allocation (allocation concealment), the type of ointment for each participant (drug or placebo) will be determined by a person not involved in the study using a randomizer, and a numbered label will be placed on the ointments.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, researcher and data analyst will be blinded. Both drug and placebo will be completely similar in terms of color, size and shape and will be presented in similar packages. In addition to the person determining the sequence of placement of people in the groups, the only person who will know the type of drug prescribed will be the research assistant, and the participants, researcher, data collectors and analysts will not be informed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Ethics Committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz university of medical science, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2023-01-28, 1401/11/08
Ethics committee reference number
IR.TBZMED.REC.1401.971

Health conditions studied

1

Description of health condition studied
Severity of episiotomy pain
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Episiotomy wound healing
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain level of episiotomy
Timepoint
At the beginning of the study (before the start of the intervention) and on the 10th day after delivery
Method of measurement
Visual Analogue Scale

2

Description
Episiotomy wound healing rate
Timepoint
At the beginning of the study (before the start of the intervention) and on the 10th day after delivery
Method of measurement
Redness, Edema, Ecchymosis, Discharge, Approximation scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants in the intervention group will use 2 cm (1 knuckle length) ointment on the ٍEpisiotomy site twice a day, 12 hours apart, for ten days. The contents of the ointment will include Propolis and Oserin (Vaseline and a little Lanolin). Propolis will be made from Royal Shahd Pirlanta bee products company, which is a beehive breeding place in Azerbaijan region, and Oserin will be made from Dr. Shahtalebi cosmetic company.
Category
Treatment - Other

2

Description
Control group: Participants in the control group will use 2 cm (1 knuckle length) ointment on the episiotomy site 2 times a day, 12 hours apart, for ten days. The prepared ointment base will be used as a placebo ointment without Propolis. If there is a need to adjust the color of the ointment, the approved pharmaceutical color will be used to match the color of the placebo and Propolis ointment.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Masoomeh Rafat Nia
Street address
School of Nursing and Midwiferyو Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3478 5229
Email
Rafatniamasume@gmail.com

2

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Masoomeh Rafat Nia
Street address
School of Nursing and Midwifery, shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3478 5229
Email
Rafatniamasume@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Research department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7310
Email
dabirkhanecent@tbzmed.ac.ir
Grant name
Grant code / Reference number
70312
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Masoomeh Rafat Nia
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3478 5229
Email
Rafatniamasume@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamali Fard
Position
Assestant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery school, Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
9876598765
Phone
+98 41 3524 5181
Email
Kamalifardm@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamali Frad
Position
Assestant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery school, Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
9876598765
Phone
+98 41 3478 5229
Email
Kamalifardm@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participants data is confidential.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...