Effectiveness of a Nursing Intervention on Quality of Life, Sexual Function, and Self-esteem in Hysterectomized Women

NCT05373550 | Unknown

• 1 other identifier: CEBB 717_2020
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical hysterectomy is second only to cesarean section as a surgical procedure in women, causing an impact on sexual function, quality of life, and self-esteem, therefore it is necessary to incorporate a comprehensive care in search of women's welfare. Objectives: To know the meaning of education in the perioperative period, in women submitted to hysterectomy for a benign cause. To determine the efficacy of a nursing educational intervention based on self-care in the improvement of sexual function, health-related quality of life, and self-esteem in women undergoing hysterectomy for benign causes. Subjects and methods: A sequential exploratory mixed-method study. For the qualitative phase, individual interviews will be conducted with women (35 to 65 years old) with the indication of hysterectomy for benign pathology attending the gynecology office, who will be contacted and invited to participate. The interviews will be analyzed using the content analysis technique. The quantitative phase will correspond to a quasi-experimental study design with a non-equivalent control group in women with indications for hysterectomy between 35 and 65 years old in two Obstetric Gynecological Hospitals in Quito. At least 26 women on the waiting list for hysterectomy for the experimental group and 26 for the comparison group will be included. Instruments: Bio-sociodemographic questionnaire, Female Sexual Function Index, SF-36, and Rosenberg Scale. The two groups will receive traditional care and the experimental group will additionally receive face-to-face nursing educational intervention with technological support. Ethical requirements will be considered. Expected results: After the nursing education intervention with technological support, women in the experimental group will improve their sexual function, health-related quality of life, and self-esteem concerning the comparison group

Conditions

Prevention of Complications Due to Hysterectomy

Keywords

Quality of Life; Sexuality; Self Concept; Hysterectomy

Outcome Measures

Primary Outcomes (1)

• Female sexual function

  The primary outcome expected from the intervention is the following to change Female Sexual Function in the hysterectomized woman. It will be measured with the Female Sexual Function Index, to achieve a score greater than 26 in the total sum of all domains, since a score less than 26 means sexual dysfunction.

  12 weeks and corresponds to the perioperative period for hysterectomy.

Secondary Outcomes (2)

• Health-related quality of life

  12 weeks and corresponds to the perioperative period for hysterectomy.

• Self-Steem

  12 weeks and corresponds to the perioperative period for hysterectomy.

Study Arms (2)

Comparison group: usual care

NO INTERVENTION

It is made up of women between 35 and 65 years old who are on the waiting list for surgical treatment (hysterectomy) of the gynecology service of the HGOLEA and receive routine care.

Experimentation group: nursing education intervention with technological support.

EXPERIMENTAL

It is made up of women between 35 and 65 years of age who are on the waiting list for surgical treatment (hysterectomy) in the gynecology service of the HGOIA. Women seen at this facility receive care similar to that previously described for the HGOLEA. This group will additionally receive the educational intervention of face-to-face nursing with technological support.

Behavioral: Effectiveness of a nursing educational intervention on quality of life, sexual function, and self-esteem in hysterectomized women: a mixed method approach.

Interventions

Effectiveness of a nursing educational intervention on quality of life, sexual function, and self-esteem in hysterectomized women: a mixed method approach. BEHAVIORAL

Effectiveness of a nursing educational intervention supported by a technological tool (Libre mujer), on quality of life, sexual function and self-esteem in hysterectomized women: a mixed method approach.

Experimentation group: nursing education intervention with technological support.

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Women with oncological pathology, complications or obstetric indication, with ectopic pregnancy, with oophorectomy, with mental illness or dementia, with a combination of several surgical procedures or some degree of physical or cognitive disability.

Sponsors & Collaborators

• Universidad de Concepcion: lead
• Universidad Central del Ecuador: collaborator

Study Sites (1)

Gynecological-Obstetric Hospital Isidro Ayora

Quito, Pichincha, 170402, Ecuador

Location

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MeSH Terms

Conditions

Sexuality

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: As blinding is a necessary condition in this type of study, the knowledge of the surveyors in the collection of the data, about the experimental group and comparison group will be safeguarded, for which the list of the participating women will be delivered in sealed envelopes and they will only know as group A and group B, both at the beginning and at the end of the study in the pre-test and post-test, with the aim of preventing certain biases in some of the stages of the study, reducing the possibility that the variables of results and their measurement are influenced by lack of blinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research director

Model Details: The design will be a sequential exploratory mixed design, which consists of an initial phase of qualitative data collection and analysis and a final phase where quantitative data are collected and analyzed. This mixed mixture allows for clear stages to be determined, with the data from one stage needing to be thoroughly analyzed before the other stage provides details about the intervention study model.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 13, 2022
• Study Start: September 13, 2021
• Primary Completion: October 1, 2021
• Study Completion: August 1, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)