]>
IRCT20201012049002N1 IRCT 2021-01-09 Tehran University of Medical Sciences Comparison between in-person and couples counseling in reducing anxiety depression and quality of life of HPV positive women Comparison of in-person and couples counseling on anxiety, depression and quality of life in HPV-positive women 2021-01-14 anticipated 120 Complete https://irct.ir/trial/53095 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block Randomization: With the size of blocks 3, 6 and 9, 40 people will be randomly assigned to 3 groups. A member of the research team who is not involved in the selection of samples, will determine the random allocation sequence using a computer program, and opaque envelopes in the package will be numbered in order to allocation concealment, Blinding description: The statistical analyst is blinded to the allocation of study groups. In this way, the statistical analyzer does not know which of the data belongs to the control or experimental group. N/A Condition 1: Anogenital (venereal) warts. Condition 2: Mild cervical dysplasia. Intervention 1: Intervention group 1: This intervention will run virtually and individually in 6 sessions (30 minutes for each session) as a day in between. Telephone counseling to support women with HPV to overcome their fears and worries will be conducted and answering their questions (about 4 times) . Six training sessions consist of two parts, each of which will be three sessions: In the first part, an educational intervention based on correcting the myths of the disease will be designed to change misunderstandings and negative perceptions about the disease, eliminate misconceptions and relieve stigma. The second part of the training will be based on lifestyle to strengthen the body immune system and eliminate the virus from the body (nutrition, exercise, sleep hygiene and sexual health). The educational booklet compiled by the researcher is presented to the patients at the end of the second session for study, which is designed based on a review of the texts and using the opinion of experts. Intervention 2: Intervention group 2: This intervention will run virtually and couple in 6 sessions (30 minutes for each session) as a day in between. Telephone counseling to support women with HPV to overcome their fears and worries will be conducted and answering their questions (about 4 times) . Six training sessions consist of two parts, each of which will be three sessions: In the first part, an educational intervention based on correcting the myths of the disease will be designed to change misunderstandings and negative perceptions about the disease, eliminate misconceptions and relieve stigma. The second part of the training will be based on lifestyle to strengthen the body immune system and eliminate the virus from the body (nutrition, exercise, sleep hygiene and sexual health). The educational booklet compiled by the researcher is presented to the patients at the end of the second session for study, which is designed based on a review of the texts and using the opinion of experts. Intervention 3: Control group: In the control group, no intervention will be performed by the researcher and patients will receive only routine care. After the trial, educational content will be provided to them. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There are no more information
public Seyedeh Tahereh Mirmolaei
Nursing and Midwifery School, Mirkhani St., Nosrat St., Tehran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4000 mirmolaei@tums.ac.ir Tehran University of Medical Sciences scientific Kowsar Qaderi
Nursing and Midwifery School, Mirkhani St., Nosrat St., Tehran
Tehran Iran (Islamic Republic of) 61054000 +98 21 6105 4000 kqaderi@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Receiving Positive result of HPV test Being literate Understanding Persian language no chronic illness no known mental illness 18 years 55 years Both A63.0 N87.0 Anogenital (venereal) warts Mild cervical dysplasia Lifestyle Lifestyle N/A Intervention group 1: This intervention will run virtually and individually in 6 sessions (30 minutes for each session) as a day in between. Telephone counseling to support women with HPV to overcome their fears and worries will be conducted and answering their questions (about 4 times) . Six training sessions consist of two parts, each of which will be three sessions: In the first part, an educational intervention based on correcting the myths of the disease will be designed to change misunderstandings and negative perceptions about the disease, eliminate misconceptions and relieve stigma. The second part of the training will be based on lifestyle to strengthen the body immune system and eliminate the virus from the body (nutrition, exercise, sleep hygiene and sexual health). The educational booklet compiled by the researcher is presented to the patients at the end of the second session for study, which is designed based on a review of the texts and using the opinion of experts. Intervention group 2: This intervention will run virtually and couple in 6 sessions (30 minutes for each session) as a day in between. Telephone counseling to support women with HPV to overcome their fears and worries will be conducted and answering their questions (about 4 times) . Six training sessions consist of two parts, each of which will be three sessions: In the first part, an educational intervention based on correcting the myths of the disease will be designed to change misunderstandings and negative perceptions about the disease, eliminate misconceptions and relieve stigma. The second part of the training will be based on lifestyle to strengthen the body immune system and eliminate the virus from the body (nutrition, exercise, sleep hygiene and sexual health). The educational booklet compiled by the researcher is presented to the patients at the end of the second session for study, which is designed based on a review of the texts and using the opinion of experts. Control group: In the control group, no intervention will be performed by the researcher and patients will receive only routine care. After the trial, educational content will be provided to them. Anxiety and Depression. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Hospital Anxiety and Depression Scale (HADS). Quality of life. Timepoint: Before and 10 weeks after intervention. Method of measurement: QoL SF-36. Tehran University of Medical Sciences Approved 2018-10-31 Ethical Commitee of School of Nursing and Midwifery and School of Rehabilitation - National Ethics C Nursing and Midwifery School, Mirkhani St., Nosrat St., Tehran Tehran Tehran Iran (Islamic Republic of)