Effectiveness comparison of online emotion regulation therapy (ERT) and online guided imagery therapy (GIT) on sexual anxiety in women with endometrial and ovarian cancer
Effectiveness comparison of online emotion regulation Therapy and online guided imagery therapy on sexual anxiety in women with endometrial and ovarian cancer
Design
Semi-experimental study conducts in parallel randomized clinical trial without blinding on 64 eligible women who have sexual anxiety. They are selected convenient sampling and randomly allocated using random allocation sequence numbers via software into 32 -women in intervention groups of ERT or GIT. They will be given the number1 to 64. Concealment is performed via closed envelope.
Settings and conduct
Baghaeipour Clinic of Shahid Sadoughi Hospital in Yazd, sampling, random allocation and psychological intervention will conduct by the second investigator, under the supervision of the first, third and the fourth investigators.
Participants/Inclusion and exclusion criteria
Inclusion age18-65 years,
Having endometrial and ovarian cancer;
Women able to have sex at least 6 weeks after surgery or chemotherapy;
Ability to participate in counseling sessions and online consultation;
Having an Android or IOS smartphone;
Having sexual anxiety based on the questionnaire;
Married and having intercourse with her husband;
Women consent to participate in research;
Ability to understand and speak Persian;
Collaboration in performing tasks;
exclusion
Recurrence of cancer;
Hospitalization;
Women undergoing vaginal brachytherapy، chemotherapy، radiation;
Women with cancer without hysterectomy;
Women with sever surgery complications, fistula or urine/stool incontinency;
Women with severe mental illness;
Neurological disorders;
Addiction.
Intervention groups
For group1(ERT) and group2 (GIT),8 counseling sessions are held weekly for 60 minutes. Both groups receive group counseling in the form of online Skyperoom and WhatsApp counseling sessions.
Main outcome variables
Change in the mean sexual anxiety scores
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220526054996N1
Registration date:2022-06-11, 1401/03/21
Registration timing:prospective
Last update:2022-06-11, 1401/03/21
Update count:0
Registration date
2022-06-11, 1401/03/21
Registrant information
Name
Farinaz Ansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3332 5015
Email address
f.ansari@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness comparison of online emotion regulation therapy (ERT) and online guided imagery therapy (GIT) on sexual anxiety in women with endometrial and ovarian cancer
Public title
Comparison of online emotion regulation therapy(ERT) and online guided imagery therapy (GIT) on sexual anxiety in women with endometrial and ovarian cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age (18 to 65 years)
Having Endometrial and Ovarian cancer
Women able to have sex after at least 6 weeks of surgery or final chemotherapy
Ability to participate in counseling sessions
Having an Android or iOS smartphone
Ability to use online consultation with a smart phone
Having Sexual Anxiety based on the Davis Sex Anxiety Questionnaire
Married women and having intercourse with her spouse
Women consent to participate in the research
Ability to understand and speak Persian
Collaborate in performing tasks
Exclusion criteria:
Recurrence of cancer
Hospitalization of patients for any reason
Women undergoing vaginal brachytherapy
Women undergoing chemotherapy on time of sampling
Women under radiation on time of sampling
Women who have not had a hysterectomy in the presence of cancer
Women with severe mental illness
Neurological disorders
Addiction to drugs and alcohol
Women with severe surgical complications like fistula or urine/stool incontinency
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible women are selected through convenience sampling method and randomly allocated using random numbers sequence that prepared by biostatistician (using the site www.random.org/sequences/) assigned into group emotion regulation Therapy (ERT) or guided imagery Therapy (GIT) (32 women in each group) by investigator based on the output of the software. Both investigator and women are not aware the name of group that each woman will be allocated. Each woman is given a code between 1 and 64. Allocation concealment is performed using closed envelope. Again, each group is randomly allocated into two subgroups of 16 women by a collogue out of research team. Thus, the study is performed with the two main groups of emotion regulation Therapy group (n = 32 ERT) and guided imagery Therapy (n = 32 GIT), which includes four subgroups of 16 women.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Bahonar Square,Yazd
City
Yazd
Province
Yazd
Postal code
8916189165
Approval date
2022-05-18, 1401/02/28
Ethics committee reference number
IR.SSU.REC.1401.014
Health conditions studied
1
Description of health condition studied
Sexual anxiety counseling
ICD-10 code
Z70
ICD-10 code description
Counseling related to sexual attitude, behavior and orientation
Primary outcomes
1
Description
Measurement of mean sexual anxiety scores in women with endometrial and ovarian cancer
Timepoint
At the baseline,Completion of the intervention in week 8 and follow-up completion of the study in week 12 in two groups
Method of measurement
Sexual Anxiety Questionnaire (Davis and et al.)
Secondary outcomes
1
Description
Mean score of wife attitude toward her spouse sexual satisfaction in two groups
Timepoint
Baseline, completion of the intervention in week 8 and follow-up of study completion in week 12
Method of measurement
With a question on a visual scale of spouse sexual satisfaction in view of wife between 1-10 by the method of self-reporting by women
Intervention groups
1
Description
Intervention group: The intervention in the emotion regulation group is done online and in a group counseling method in the Skyroom and WhatsApp in 8 sessions of 60 minutes, once a week by the second investigator under the supervision of the first and the fourth couple therapist investigators. Content of sessions includes psychoeducation for sexual performance, psychoeducation for emotion and sexual emotion regulation, selection of situation and acceptance to emotional sexual response, correction of situation, extension of attention and reevaluation , self acceptance and compassion, regulation of sexual response. At the beginning of each session, a summary of the content of the previous sessions will be reviewed and the tasks assigned to the previous session will be reviewed by the counselor to assess the state of sexual anxiety improvement in each session. Women are asked to participate in online counseling discussions and ask questions. The consultant will also ask questions about the topics of the meeting to get more women involved. At the end of each session, a summary of the important issues is presented and the questions of the individuals are answered and the women are asked to do their homework until the next session.
Category
Behavior
2
Description
Intervention group: The intervention in the Guided imagery group is done online and in a group in the Skyroom and WhatsApp space in 8 sessions of 60 minutes, once a week by the second investigator under the supervision of the first and the fourth couple therapist investigators. Content of sessions includes psychoeducation for familiar with GIT, recognition of disturbance images and thoughts and their relation with sexual mood and sexual behavior, training of guided imaginary skills, thoughts rotation training and thoughts review, cognitive reconstruction of negative sexual thoughts, evaluation of sexual negative thoughts management , and assessment of sexual behaviors. At the beginning of each session, a summary of the content of the previous sessions will be reviewed and the tasks assigned to the previous session will be reviewed by the counselor to assess the state of sexual anxiety improvement in each session. Women are asked to participate in online counseling discussions and ask questions. At the end of each session, a summary of the important issues is presented and the questions of the individuals are answered and the women are asked to do their homework until the next session.