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

The Effect of Counseling Grounded in Watson's Human Caring Theory on Reproductive Concerns in Women Diagnosed with Cancer: a Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06757465
Enrollment
50
Registered
2025-01-03
Start date
2024-01-01
Completion date
2024-09-15
Last updated
2025-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reproductive Health

Keywords

Cancer, Counseling, Reproductive Concerns, Women

Brief summary

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.

Detailed description

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.

Interventions

OTHERCounseling 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.

Sponsors

Ege University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Masking description

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.

Intervention model description

a single-blind, randomized controlled clinical trial, parallel

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Exclusion criteria

* Being in menopause, * Having had a hysterectomy, * Being in Stage IV of the cancer diagnosed.

Design outcomes

Primary

MeasureTime frameDescription
The Reproductive Concerns After Cancer ScaleChange from before implementation and 4th week of practice.The scale assesses fertility and parenting concerns. It consists of 18 items. The lowest total score from the scale is 18 and the highest is 90. As the score increases, the level of reproductive concerns increases.
The Patient Satisfaction Evaluation Form Based on Watson's Processes of HealingChange from 4th week of practice.It is used to evaluate nursing care based on Watson's Human Caring Theory. It consists of 6 questions. The total highest score from this evaluation form is 35, and the lowest score is five.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026