Determining the effect of Rosa damascena extract on anxiety and sexual function in primiparous breastfeeding women
Design
This study will be a double-blind randomized controlled clinical trial with parallel, on 94 breastfeeding women with low sexual function score and high anxiety score. eligible participants will be randomised into intervention and control group using Stata software version 12. with a ratio of 1: 1
Settings and conduct
East Ahvaz Health Center No. 1, patients' height will be measured by a standard stadiometer and their weight will be measured by a digital scale. The nature of the drug and placebo will be revealed after analyzing the results. Each person will be assigned to a intervention group or placebo based on a random number table and the chances of individuals being in each group will be exactly the same.
Participants/Inclusion and exclusion criteria
1. Breastfeeding
2. At least 6 weeks to 12 months after delivery
3. Having a spouse
5. Primiparous
6. Single
7. Literacy
8 scores less than 26 of the Sexual Function Questionnaire
9. And get a score of 53-20 from the Spielberger questionnaire
No entry:
1. History of allergy to Mohammadi flower and its derivatives
2. Specific disease of the breast and uterus
3. Taking certain medications that affect sexual function (such as antidepressants, aspirin, and anticoagulants)
4. Feeding the baby with powdered milk
5. Smoking or alcohol consumption
6. Pregnancy
Intervention groups
Each person will be assigned to a control group or placebo based on a random number table, and their chances of being in each group will be exactly the same.
Main outcome variables
Sexual function (libido; arousal; lubrication; orgasm; satisfaction; pain)
overt and covert anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211015052775N1
Registration date:2022-02-14, 1400/11/25
Registration timing:prospective
Last update:2022-02-14, 1400/11/25
Update count:0
Registration date
2022-02-14, 1400/11/25
Registrant information
Name
Gohar Akbarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8333
Email address
akbarzadeh.g@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rosa damascena extract on anxiety and sexual function of primi parous breastfeeding women
Public title
The effect of Rosa damascena on anxiety and sexual function in breastfeeding women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Breastfeeding
At least 6 weeks up to 12 months after delivery
Having a spouse
Primiparous
Single fetus
Basic Literacy
Scores less than 26 from the Sexual Function Questionnaire
Scores 20-53 from the Spielberger questionnaire
Exclusion criteria:
History of allergy to Rosa damascana and its derivatives
Specific disease of the breast and uterus
Taking certain medications that affect sexual function (such as antidepressants, aspirin, and anticoagulants)
Feeding the baby with formula
Smoking or alcohol consumption5
Pregnancy
A history of any mental illness or severe trauma in the last 6 months
Age
From 15 years old to 45 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher and participant in this study are unaware of the drug or placebo of Rosa Damascena capsules and will be prepared and coded by the pharmacist of the capsules. The drug and placebo will be the same in terms of appearance, such as packaging and color. The nature of the drug and placebo will be revealed after analyzing the results. Each person will be assigned to a control group or placebo based on a random number table and the chances of individuals being in each group will be exactly the same.The nature of the drug and placebo becomes apparent after analyzing the results.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and participant in this study are unaware of the drug or placebo of Rosa damascen capsules and capsules will be prepared and coded by the pharmacist . The drug and placebo will be the similar in terms of appearance, such as packaging and color. The nature of the drug and placebo will be revealed after analyzing the results. Each person will be assigned to an intervention group or placebo based on a table of random numbers and the chances of individuals attending each group will be exactly the same.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Golestan Ave, Ahvaz Jundishapur University of Medical Science, Nursing and Midwifery School, Midwifery Department
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2022-01-19, 1400/10/29
Ethics committee reference number
IR.AJUMS.REC.1400.614
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
2
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
Score less than 26.5 in the Sexual Function Questionnaire (FSFI) and a score of 53-20 from the overt anxiety questionnaire and a score of 20-53 from the hidden anxiety section (STAI).
Timepoint
8 weeks
Method of measurement
The Sexual Function Questionnaire (FSFI) and the overt and covert anxiety questionnaire (STAI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: At first, Rosa damascena petals will be purchased by a researcher from a reputable shop. Then the plant will be dried, ground and extracted by meceration method (soaking) with 70% ethanol for 48 hours . The hydroalcoholic solution is then separated from the plant particles by filter paper and the remaining ethanol is collected by a rotary apparatus. The concentrated extract is stored in an incubator at 37 ° C and dried. The dried extract is then stored at minus 20 ° C to make capsules containing 400 mg of the extract. At the beginning of the study, participants are given 56 capsules (400 mg) that have the same appearance and their codes are determined by a pharmacist participant should take two tablets every morning and night with a glass of water for 8 weeks.participants will be requested to attend the clinic in (4 and 8 weeks later) are explained to the breastfeeding mother. four weeks later, they are given another 56 capsules to take twice daily. The participants receive a phone call to reminding about accurate usage. Eight weeks after treatment, they will be requeste to complete. FSFI and Spielberger questionnaires again. A sheet will also be reported to the company to record symptoms or complaints and when to use it. They are taught how to fill out the forms and are asked to contact the researcher or refer to the center if they have any problems. Participants will consider as a drop-out if they not taking medication for to continuous they per week. In addition, in order to be sure aout taking the medicine, the clients will be reminded to return the empty drug containers when they come for re-examination.Control group: This group receives placebo in such a way that the capsules will be filled with starch. At the beginning of the study, 56 400 mg capsules are given to the participants which have the same appearance and their codes are specified by the pharmacist for 8 days. Every day of the week, two are consumed in the morning and at night with a glass of water. The duration of use and the date of return (4 weeks and 8 weeks later) are explained to the breastfeeding mother. 4 weeks later, they are given another 56 capsules to take two daily. The client's phone number is dialed to remind him of the visiting times. After treatment, they will be given the FSFI and Spielberger questionnaires again to complete. The participant will also be given a worksheet to record symptoms or complaints and when to use it. They are taught how to fill out the forms and are asked to contact the researcher or refer to the center if they have any problems. Participants will consider medication or placebo as a drop if not used twice a week. In addition, in order to be more sure of taking the medicine, the clients will be reminded to deliver the empty envelope of the medicine when they come for re-examination.
Category
Treatment - Drugs
2
Description
control group: In this group, research units consume one placebo capsule every 12 hours for 8 weeks. Each of these capsules contains 400 mg of starch powder and is made with the appearance and packaging similar to Rosa Damascena capsule in the pharmacology department of medicinal plants by a respected pharmacist.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
East Ahvaz Health Center No. 1
Full name of responsible person
Engineer Amraleh Mardani
Street address
East Ahvaz Health Center, in front of Haft Tir Park, Shahid Rastegari St, Ayatollah Behbahani Highway
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 2215 6333
Email
info@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoosh Zakerkish
Street address
Ahvaz Jundishapur University of Medical Sciences., Deputy of research and technology., Ahvaz., Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahvaz Jundishapur 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
Ahvaz University of Medical Sciences
Full name of responsible person
Gohar Akbarzadeh
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Midwifery Department, Nursing And Midwifery School, Ahvaz Jundishapur Of Medical Science, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8333
Fax
Email
akbarzadeh.g@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvin Abedi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Midwifery Department, Nursing and Midwifery School, Ahvaz Jundishapur University of Medical Science, Golestan Ave, Ahvaz, Iran,
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
parvinabedi@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Gohar Akbarzadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Miremad, Ghazali Ave, Imam Hasan Street, Akbarabad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591888737
Phone
+98 917 343 8381
Email
Akbarzadegohar1423@gmail.com
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
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
To do valid research work
From where data/document is obtainable
To the general respondent: Gohar Akbarzadeh
What processes are involved for a request to access data/document
The request will be answered at the earliest opportunity