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IRCT20180218038783N2 IRCT 2022-12-23 Babol University of Medical Sciences The effectiveness of olive and black seed oil combination in pain intensity and episiotomy wound healing The effectiveness of olive and black seed oil combination in pain intensity and episiotomy wound healing in prim parous women referred to hospitals under the auspices of Babol University of Medical Sciences 2023-02-05 anticipated 108 Complete https://irct.ir/trial/67451 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The researcher will select the samples according to the Inclusion criteria and assign them randomly (using the block randomized method) to two groups of intervention and routine care. Eligible people are placed in one of three groups A: 36 people, B: 36 people, and C: 36 people, using permuted block randomization and open label. The size of the blocks is 6 and in each block each intervention group will be repeated twice. 18 blocks of 6 will be produced to create a sequence of size 108, Blinding description: In order to hide the list of random allocation, a special code will be assigned to each of the intervention groups, which only the main executor of the project (supervisor) will be aware of. Also, the second moderator, who is a student and evaluator of the study and the person who performs the statistical analysis, will not know about the codes assigned to the drugs. N/A Condition 1: Episiotomy pain intensity. Condition 2: Episiotomy wound repair. Intervention 1: Intervention group 1: recipient of black seed oil and olive:All the subjects of the study will be taught how to follow the health tips after childbirth, and the samples of the intervention group will be taught how to use the container containing the oils. In such a way that they use the container containing black seed and olive oil with a dose of 10 drops locally and three times a day 24 hours after giving birth, for 10 days. The researcher also examines the severity of perineal pain and healing of episiotomy wound in the first 24 hours after delivery and ten days after that. Intervention 2: intervention group 2: Recipient of olive oil alone:All the subjects of the study will be taught how to follow the health tips after childbirth, and the samples of the intervention group will be taught how to use the container containing the oils. In such a way that they use a container containing olive oil with a dose of 10 drops locally and three times a day 24 hours after giving birth, for 10 days. The researcher also examines the severity of perineal pain and healing of episiotomy wound in the first 24 hours after delivery and ten days after that. Intervention 3: Control group: They receive routine cares. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Fereshteh Behmanesh
Babol University of Medical Sciences, Keshavarz street, Kargar Ave
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 0504 f.behmanesh2015@gmail.com Babol University of Medical Sciences scientific Fereshteh Behmanesh
Babol University of Medical Sciences, Keshavarz street, Kargar Ave
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 0504 f.behmanesh2015@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Primiparous women Normal delivery with episiotomy Having literacy BMI < 30 15 years 45 years Female The personal unwillingness of the participants to continue the study, Women who do not use oils regularly. 4th degree tear History of diagnosed skin dermatitis History of allergy and eczema diagnosed to plants History of gestational diabetes and obvious G89 O86.0 Pain, not elsewhere classified Infection of obstetric surgical wound Treatment - Other Treatment - Other N/A Intervention group 1: recipient of black seed oil and olive:All the subjects of the study will be taught how to follow the health tips after childbirth, and the samples of the intervention group will be taught how to use the container containing the oils. In such a way that they use the container containing black seed and olive oil with a dose of 10 drops locally and three times a day 24 hours after giving birth, for 10 days. The researcher also examines the severity of perineal pain and healing of episiotomy wound in the first 24 hours after delivery and ten days after that. intervention group 2: Recipient of olive oil alone:All the subjects of the study will be taught how to follow the health tips after childbirth, and the samples of the intervention group will be taught how to use the container containing the oils. In such a way that they use a container containing olive oil with a dose of 10 drops locally and three times a day 24 hours after giving birth, for 10 days. The researcher also examines the severity of perineal pain and healing of episiotomy wound in the first 24 hours after delivery and ten days after that. Control group: They receive routine cares. The intensity of pain in the episiotomy area is based on the person's statements, where 0 means the least pain and 10 means the most possible pain. Timepoint: 24 hours after delivery (before the start of the intervention) and on the 10th day after starting the topical use of oils. Method of measurement: 10 cm pain ruler scale. Healing of episiotomy wound based on measuring the variables of swelling, bruising, redness and the distance between the two edges of episiotomy wound in lithotomy position. Timepoint: 24 hours after delivery (before the start of the intervention) and on the 10th day after starting the topical use of oils. Method of measurement: ٍEpisiotomy wound healing REEDA scale. Burning and itching. Timepoint: The first ten days after delivery. Method of measurement: Examination. Episiotomy opening. Timepoint: The first ten days after delivery. Method of measurement: Examination. The need for painkillers. Timepoint: The first ten days after delivery. Method of measurement: Examination. Babol University of Medical Sciences Approved 2022-12-12 Ethics Committee of Babol University of Medical Sciences Mazandaran, Babol, Ganj Afrooz Street, Babol University of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)