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IRCT20230720058860N1 IRCT 2023-11-27 Mashhad University of Medical Sciences A study on the effect of ointment of pistacia atlantica oil on the prevention of stretch marks in primigravid wemon A study on the effect of ointment of pistacia atlantica oil on the prevention of stretch marks in primigravid wemon 2023-10-07 anticipated 140 Complete https://irct.ir/trial/72691 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: On the first day of visit, some ointment is used on the inside of the forearm of the research unit, if no sensitivity occurs after 15 minutes, the severity of stretch marks, erythema and itching in the abdominal area, with the help of Davy's checklists and Kamini's checklists And it is checked.Then he explains how to use Beneh Ointment to the research unit and asks him to use 3 cm of 10% Oserin-based Beneh Ointment on the abdomen every day and emphasizes that during and after using Beneh Ointment on the abdomen don't massage and perform this procedure for 8 weeks in a row.Every 4 weeks, the research units must visit the research site and be evaluated by the researcher. After 8 consecutive weeks of intervention, immediately after the end of the intervention, the research units will return to the research environment to be examined again by the researcher.On the day after the end of the intervention, the Davi, Atwal and Kamini checklists are completed again by the researcher. The study and follow-up process in the control group (placebo) is the same as the intervention group, but instead of the placebo ointment (Oserin) that is in the cans It is similar to a can of ointment, they will use it, Randomization description: Allocation Concealment: envelopes will be prepared as many as the sample size (140). Half of the envelopes are for the intervention group and the other half for the control group. Inside the sealed envelopes, the type of group (intervention or control) will be specified on a sheet. Then the envelopes are closed. When the research units enter the research environment, an envelope will be randomly selected for them and the type of group to which the sample will be assigned will be revealed, Blinding description: When preparing medicine and placebo, the pharmacist gives a code of one or two to their cans, and the code will remain hidden for the researcher, research unit and data analyst until the end of the analysis. 1-2 stretch marks. Intervention 1: Intervention group: The intervention process in the intervention group is such that on the first day of the research units' visit to the research environment, the researcher uses some ointment on the skin of the inner forearm of the research unit, if after 15 minutes there is no itching, burning, Inflammation and discoloration did not occur (lack of drug sensitivity), the severity of striae, erythema and itching in the abdominal area, with the help of medication checklists (for this purpose, first, with the help of a surgical marker on the abdomen of the research unit, two perpendicular lines If their point of intersection is on the navel, he divides it into four equal parts and scores each part according to the checklist, then adds the total scores of the four parts together and determines the severity of striae according to the checklist, and completes the Kamini and Etowal checklists. Then he explains how to use Beneh ointment to the research unit and asks him to use 3 cm of 10% Oserin-based Beneh ointment on the stomach every day and emphasizes that during and after using the ointment Do not massage the abdomen and perform this procedure for 8 consecutive weeks. The researcher will follow up the use of the ointment once a week by the research units (both in the placebo group and in the intervention group) by telephone. . and asks them to fill in the checklist of the study process. In addition to this, the researcher forms a group in Eta, Yes or Rubika so that all the research units are placed in that group after entering the study, and they are reminded to use the drug daily. and asks the research units to visit the research site every 4 weeks and be evaluated by the researcher. After 8 consecutive weeks when the intervention was carried out, immediately on the day after the end of the intervention, the research units will return to the research environment to be re-evaluated by the researcher. The researcher should be examined. It should be noted that on the day after the end of the intervention, Davy, Atwal and Kamini checklists are completed again by the researcher. In addition to the examination checklists, questionnaires. Intervention 2: Control group: The study and follow-up process in the control group (placebo) is the same as the intervention group, but instead of Beneh ointment, they will use a placebo (Oserin) which is in the same cans as Beneh ointment. At the end of the intervention, the study process checklist will be received from the research unit. Yes - There is a plan to make this available What will be shared: A study on the effect of ointment of pistacia atlantica oil on the prevention of stretch marks in primigravid wemon When: Available in the journal after publication To whom: All people who are interested in the article Conditions: Promoting the method of preventing pregnancy stretch marks Where to obtain: They send email to the corresponding author How to obtain: Explain the reasons for requesting the article in the email Comments:
public Dr. Kobra Mirzaei
No. Azadi Ave., Kharazmi Blvd., Mashhad Town
Mashhad Iran (Islamic Republic of) 9117712390 +98 938 420 2290 Mirzakhanik@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Kobra Mirza Khani
No. Azadi Ave., Shahib Kharazmi Blvd., Mashhad Town
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3189 2105 Mirzakhanik@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Informed consent to participate in the study Age between 20 and 35 years Being pregnant for the first time Pregnancy age between 22 and 26 weeks Singleton pregnancy Not using corticosteroids and any type of topical or systemic corticosteroids Not using any kind of cream or oil in the abdominal area Not suffering from hydramnios Body mass index at the beginning of pregnancy or in the last trimester of the first trimester should be between 18.50 and 30 Mother's absence of Cushing's disease The absence of the mother from Marfan's disease The absence of the mother from anorexia nervosa The absence of the mother from chronic liver disease The absence of any type of lesion or wound at the intervention site Not having diabetes No allergy to Beneh ointment or no history of allergy to Beneh fruit 20 years 35 years Female Reluctance to continue cooperation with the research unit Occurrence of hydramnios. Use of corticosteroid drugs (local and systematic). Use of any type of cream or oil on the abdominal area during the study Non-consecutive days during the study Rupture of fetal membranes, childbirth or termination of pregnancy for any reason Having gestational diabetes during the study O99.7 Diseases of the skin and subcutaneous tissue complicating pregnancy, childbirth and the puerperium. Treatment - Drugs Prevention Intervention group: The intervention process in the intervention group is such that on the first day of the research units' visit to the research environment, the researcher uses some ointment on the skin of the inner forearm of the research unit, if after 15 minutes there is no itching, burning, Inflammation and discoloration did not occur (lack of drug sensitivity), the severity of striae, erythema and itching in the abdominal area, with the help of medication checklists (for this purpose, first, with the help of a surgical marker on the abdomen of the research unit, two perpendicular lines If their point of intersection is on the navel, he divides it into four equal parts and scores each part according to the checklist, then adds the total scores of the four parts together and determines the severity of striae according to the checklist, and completes the Kamini and Etowal checklists. Then he explains how to use Beneh ointment to the research unit and asks him to use 3 cm of 10% Oserin-based Beneh ointment on the stomach every day and emphasizes that during and after using the ointment Do not massage the abdomen and perform this procedure for 8 consecutive weeks. The researcher will follow up the use of the ointment once a week by the research units (both in the placebo group and in the intervention group) by telephone. . and asks them to fill in the checklist of the study process. In addition to this, the researcher forms a group in Eta, Yes or Rubika so that all the research units are placed in that group after entering the study, and they are reminded to use the drug daily. and asks the research units to visit the research site every 4 weeks and be evaluated by the researcher. After 8 consecutive weeks when the intervention was carried out, immediately on the day after the end of the intervention, the research units will return to the research environment to be re-evaluated by the researcher. The researcher should be examined. It should be noted that on the day after the end of the intervention, Davy, Atwal and Kamini checklists are completed again by the researcher. In addition to the examination checklists, questionnaires. Control group: The study and follow-up process in the control group (placebo) is the same as the intervention group, but instead of Beneh ointment, they will use a placebo (Oserin) which is in the same cans as Beneh ointment. At the end of the intervention, the study process checklist will be received from the research unit. Itching. Timepoint: First day of visit and the day after the end of the intervention. Method of measurement: Kamini checklist. Erythema. Timepoint: First day of visit and the day after the end of the intervention. Method of measurement: Otwal checklist. Striae. Timepoint: First day of visit and the day after the end of the intervention. Method of measurement: Davey checklist. Complication of the intervention. Timepoint: the day after the end of the intervention. Method of measurement: Copmlications checklist. Satisfaction with the intervention. Timepoint: the day after the end of the intervention. Method of measurement: Intervention satisfaction questionnare. Mashhad University of Medical Sciences Approved 2023-10-17 Mashhad University of Medical Science No. Azadi Ave., Kharazmi Blvd., Mashhad Town Mashhad Razavi Khorasan Iran (Islamic Republic of)