]>
IRCT20211015052775N1 IRCT 2022-02-14 Ahvaz University of Medical Sciences The effect of Rosa damascena on anxiety and sexual function in breastfeeding women The effect of Rosa damascena extract on anxiety and sexual function of primi parous breastfeeding women 2022-02-20 anticipated 94 Complete https://irct.ir/trial/61375 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 1-2 Condition 1: anxiety. Condition 2: Sexual dysfunction. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentifiable individuals When: Access period starts 6 months after the results are published To whom: It will be available to researchers working in academic and scientific institutions Conditions: To do valid research work Where to obtain: To the general respondent: Gohar Akbarzadeh How to obtain: The request will be answered at the earliest opportunity Comments:
public Gohar Akbarzadeh
Midwifery Department, Nursing And Midwifery School, Ahvaz Jundishapur Of Medical Science, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 1579461357 +98 61 3373 8333 akbarzadeh.g@ajums.ac.ir Ahvaz University of Medical Sciences scientific Parvin Abedi
Midwifery Department, Nursing and Midwifery School, Ahvaz Jundishapur University of Medical Science, Golestan Ave, Ahvaz, Iran,
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8331 parvinabedi@ymail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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 15 years 45 years Female 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 F41.1 F52 Generalized anxiety disorder Sexual dysfunction, not caused by organic disorder or disease Treatment - Drugs Placebo 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. 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. 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). Ahvaz Jundishapur University of Medical Sciences Approved 2022-01-19 Ethics Committee of Ahwaz University of Medical Sciences Golestan Ave, Ahvaz Jundishapur University of Medical Science, Nursing and Midwifery School, Midwifery Department Ahwaz Khouzestan Iran (Islamic Republic of)