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IRCT20110826007418N6 IRCT 2021-10-11 Tabriz University of Medical Sciences The effect of counseling with cognitive-behavioral approach on anxiety and stress and quality of life of mothers of girls with early onset of puberty symptoms ندارد The effect of counseling with cognitive-behavioral approach on anxiety and stress and quality of life of mothers of girls with early onset of puberty symptoms: a quasi-experimental study 2021-10-12 anticipated 60 Complete https://irct.ir/trial/57346 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be assigned to two intervention groups (receiving cognitive-behavioral counseling) and the control group by random blocking method with 4 and 6 block sizes and 1: 1 allocation ratio. To conceal the type of intervention, it will be written on a piece of paper and numbered in a series of opaque envelopes. The envelopes will be opened in the order in which the participants enter the study and the type of group will be determined. Random allocation and preparation of envelopes will be done by a person not involved in sampling and data collection. N/A Condition 1: Anxiety. Condition 2: Stress. Condition 3: Quality of Life. Intervention 1: Intervention group: 8 sessions of cognitive-behavioral counseling for 45-60 minutes once a week in a quiet environment and in groups (5 to 7 people in each group) will be held. The content of these sessions includes initial psychological assessment, rearrangement of concepts, use of clinical skills, strengthening of skills and how to use them, generalization and maintenance, follow-up and evaluation after the intervention. Intervention 2: Control group: The participants of the control group will receive an educational booklet on puberty and health issues during this period. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participant data is confidential
public Faranak Rahimi
South Shariati St., School of Nursing and Midwifery
Tabriz Iran (Islamic Republic of) 5138947979 +98 41 3177 2048 faranak.rahimi94@gmail.com Tabriz University of Medical Sciences scientific Parisa Yavarikia
South Shariati St., School of Nursing and Midwifery
Tabriz Iran (Islamic Republic of) 5138947979 +98 41 1479 6770 yavarikiap@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Having daughter with the age under 10 year Mothers with at least guidance school literacy Having a daughter with onset of pubertats praecox symptoms 7 years 10 years Female Having a history of mental disease according to the version of the person himself. Experience of a severe mental crisis during the last 3 months, such as the death of relatives, according to the version of the person himself. using the neuroleptics drugs by mothers. Mothers who have had physically and mentally other problems Participation in other similar studies F41.9 Z73.3 Anxiety disorder, unspecified Stress, not elsewhere classified Quality life Behavior N/A Intervention group: 8 sessions of cognitive-behavioral counseling for 45-60 minutes once a week in a quiet environment and in groups (5 to 7 people in each group) will be held. The content of these sessions includes initial psychological assessment, rearrangement of concepts, use of clinical skills, strengthening of skills and how to use them, generalization and maintenance, follow-up and evaluation after the intervention. Control group: The participants of the control group will receive an educational booklet on puberty and health issues during this period. Stress. Timepoint: Before and after the intervention. Method of measurement: Perceived stress questionnaire. Anxiety. Timepoint: Before and after the intervention. Method of measurement: Spiel berger Questionnaire. Quality of Life. Timepoint: Before and after the intervention. Method of measurement: SF36 questionnaire. Tabriz University of Medical Sciences Approved 2021-06-09 Ethics Committee of Tabriz University of Medical Sciences South Shariati St. - School of Nursing and Midwifery, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)