Women Diagnosed with Cancer & Reproductive Concerns & Watson's Human Caring Theory &Counselling

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a single-blind randomized controlled experimental study with a pre-test post-test design to examine the effects of counseling based on Watson's Human Caring Theory given to women between the ages of 18-45 diagnosed with cancer on fertility concerns.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fertility Supportive Behavior Education Based On Watson's Theory Of Human Care

NCT06591637

Infertility, Female IVF

COMPLETED NA

Effects of Watson's Human Caring Theory-Based Nursing Care on Fear of Childbirth and Birth Experience

NCT07321457

Fear of Childbirth Childbirth Experience

COMPLETED NA

Preconception Care for Couples Planning Pregnancy

NCT06272188

Preconception Care, Preconception Risk

NOT_YET_RECRUITING NA

Effect of Back Massage on ınfertılıty Stress, Sexual satısfactıon and marrıage Harmony ın ınfertılıty Couples

NCT06515067

Sexual Activity Infertility Stress

COMPLETED NA

Women's Quality of Life, Sexual Life and Psychological State in Patients Undergoing Embryo Transfers

NCT04131452

Infertility, Female Anxiety State Depression +2 more

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Reproductive concerns, one of the important problems affecting the quality of life of women diagnosed with cancer, is becoming a critical problem that needs to be addressed with both psychological and social dimensions when combined with concerns about the future. This study aims to examine the effect of counseling on reproductive concerns in women diagnosed with cancer, based on Watson's Human Caring Theory and an interview guide prepared by the researcher.

A randomized controlled experimental study with a pre-test-post-test design was conducted to examine the effects of counseling based on Watson's Human Caring Theory given to women between the ages of 18-45 diagnosed with cancer on reproductive concerns. The universe of the study consisted of female patients diagnosed with cancer between the ages of 18-45 who applied to the Department of Obstetrics and Gynecology (Family Planning and Infertility Research and Application Center and Gynecology Oncology Clinic), Oncology Department and General Surgery Department of Ege University Hospital. The research was conducted in the designated clinics of Ege University Faculty of Medicine Hospital between January 1, 2024 and September 15, 2024. The sample of the research consisted of 50 women diagnosed with cancer, 25 intervention and 25 controls. In the data collection process of the study, a "Participant Information Form" and a " "Reproductive Concerns After Cancer Scale" will be administered in the pre-test for both intervention and control groups. For the control group, four weeks after the pre-test, the "Reproductive Concerns After Cancer Scale" and the "Patient Satisfaction Evaluation Form According to Watson's Healing Processes" will be applied. For the intervention group, counseling sessions grounded in Watson's Human Caring Theory will be conducted in three sessions, and a post-test will be administered four weeks later.

The study, it was determined that the reproductive concerns levels of women in the intervention group who received counseling education based on Watson's Theory of Human Caring were significantly lower (p \< 0.05). The patient satisfaction assessment scores based on the improvement processes showed a statistically significant difference between the intervention and control groups. The scores of the intervention group were found to be higher compared to the control group (p \< 0.05). The Patient Satisfaction Evaluation Form scores based on Watson's Processes of Healing showed a statistically significant difference between the intervention and control groups. The scores of the intervention group were found to be higher compared to the control group (p \< 0.05). Counseling based on Watson's Theory of Human Caring was found to reduce reproductive concerns and improve patient satisfaction based on Watson's Processes of Healing in women diagnosed with cancer.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Reproductive Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a single-blind, randomized controlled clinical trial, parallel

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

The randomization list for the study sample size of 50 women was created by a statistician. According to the list, women were divided into two groups as intervention (A) and control (B). Data were collected by a fellow who was not in the study. The fellow responsible for the data collection process collected the data without knowing which group the participants belonged to. This approach was preferred to prevent bias in the measurements and to increase the reliability of the results.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Counseling for reproductive concerns in women diagnosed with cancer

In this study, a total of 75 interviews were conducted with 25 participants in the intervention group in three sessions. During the interviews, counseling training based on Watson IBK developed by the researchers was applied. Each session lasted between 30-45 minutes per participant. The first session was conducted face-to-face, and the second and third sessions were conducted using online platforms within the scope of telehealth applications. Sessions were structured according to the individual needs of the participants and the durations were arranged flexibly when necessary. Immediately after the sessions of counseling training based on Watson IBC were applied, the "the Reproductive Concerns After Cancer Scale " and "the Patient Satisfaction Evaluation Form Based on Watson's Processes of Healin" were applied as interim tests to measure the effect of counseling on reproductive concerns levels of the patients. These tests were repeated 4 weeks after the end of the training.

Group Type EXPERIMENTAL

Counseling education based on Watson's Theory of Human Caring

Intervention Type OTHER

In this study, a total of 75 interviews were conducted with 25 participants in the intervention group in three sessions. During the interviews, counseling training based on Watson IBK developed by the researchers was applied. Each session lasted between 30-45 minutes per participant. The first session was conducted face-to-face, and the second and third sessions were conducted using online platforms (Zoom, Microsoft Teams, WhatsApp video call) within the scope of telehealth applications. Sessions were structured according to the individual needs of the participants and the durations were arranged flexibly when necessary. Telehealth applications provided easy access to the participants during the counseling process and supported the continuity of individual counseling services.

Control

No intervention was made to the participants in the control group after the pre-test was applied as part of the data collection process. The women in the control group received the standard counseling service routinely applied in the clinic.

After the patients were met, detailed information about the study was given, their informed consent was obtained and the contact information of the researcher was provided to them. 4 weeks after the pre-test, "the Reproductive Concerns After Cancer Scale" and "the Patient Satisfaction Evaluation Form Based on Watson's Processes of Healing" were applied to the participants in the control group as a post-test.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Counseling education based on Watson's Theory of Human Caring

In this study, a total of 75 interviews were conducted with 25 participants in the intervention group in three sessions. During the interviews, counseling training based on Watson IBK developed by the researchers was applied. Each session lasted between 30-45 minutes per participant. The first session was conducted face-to-face, and the second and third sessions were conducted using online platforms (Zoom, Microsoft Teams, WhatsApp video call) within the scope of telehealth applications. Sessions were structured according to the individual needs of the participants and the durations were arranged flexibly when necessary. Telehealth applications provided easy access to the participants during the counseling process and supported the continuity of individual counseling services.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Being of reproductive age between 18-45 years,
* Not starting chemotherapy and radiotherapy treatment,
* Having no vision, hearing or mental problems,
* Knowing how to read and write and speaking Turkish,
* Agreeing to participate in the study voluntarily.