Sexual counseling for women who withdraw the breast

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-33tdwy
• Date of registration: 19/06/2017
• Prospective Registration: No
• Primary sponsor: Maternidade Escola Assis Chateaubriand
• Public title: Sexual counseling for women who withdraw the breast
• Scientific title: Intervention of Sexual Counselling for mastectomized: randomized controlled clinical trial
• Date of first enrolment: 11/01/2017
• Recruitment status: Data analysis completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-33tdwy
• Study type: Intervention
• Study design: Clinical trial, randomized; Controlled, parallel, double blind, with 2 arms
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Natalia Gondim de Almeida
• Affiliation: Universidade Estadual do Ceará

• Name: Natalia Gondim de Almeida
• Affiliation: Universidade Estadual do Ceará

Key inclusion & exclusion criteria

Inclusion criteria: Mastectomized women; To have at least six months of surgery; To be over 18 years of age;
To have started sexual activity
Exclusion criteria: Mastectomized women taking antidepressants; Mastectomized women with disabling diseases that prevent the sexual act.

Age minimum: 18Y
Age maximum: 100Y
Gender: F

Health Condition(s) or Problem(s) studied

M01.975

F01.145.802.975

Women, Mastectomy, Sexuality, Quality of life

E04.466

I01.800

Intervention(s)

Behavioural

V03.175.250

Experimental group: 9 mastectomized women will receive sexual counseling, based on the PILSET model, the intervention will be applied in weekly meetings for 5 weeks. Sessions will last for up to 2 hours. 1st meeting: permission (discussion on the theme and concerns about sexuality), 2nd meeting: limited information (clarifies on the physiology of sexual response and anatomy of the female genitalia, 3rd meeting: specific suggestion (advise and suggest changes in sexual behavior according to With criteria based on the physiology of the sexual response, and guide the change of attitude so that the woman goes on to have a more assertive behavior), 4th meeting: permission, limited information and specific suggestion (will resume aspects of the previous sessions and build history with fantasies Sexual intercourse), 5th meeting: sexual therapy (after closure the patient who needs it will be referred for sexual therapy). Control group: a group with 8 women will be provided, providing sexual counseling in oral explanation format, active control, performing a health education On sexuality, containing the same information used in the experimental group, in this group the information will be provided in a single meeting. Women will be compared by scoring scores from the Female Sexual Function Index (FSFI) and World Health
Organization Quality bref (WHOQOL-bre

F04.754.137

Primary Outcome(s)

Mean difference in the scoring scores of the World Health Organization Quality bref (WHOQOL-bref), From the observation of a variation of at least 10% in the pre- and post-intervention measurements

Mean difference in the scoring scores of the Female Sexual Function Index (FSFI), From the observation of a variation of at least 10% in the pre- and post-intervention measurements

Secondary Outcome(s)

Secondary outcomes are not expected

Source(s) of Monetary Support

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior

Secondary Sponsor(s)

Maternidade Escola Assis Chateaubriand