The Effect of Digital Technology-Supported Education on Patients Undergoing Breast Reconstruction After Mastectomy: A Randomized Controlled Study

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBaskent University

About this trial

The goal of this randomized, controlled study is to test the effectiveness of digital technology-supported education on patients undergoing breast reconstruction after mastectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being diagnosed with stage 1, 2, or 3 breast cancer

Planned to undergo immediate breast reconstruction after mastectomy for the first time

Being between 18 to 75 years old

Able to use smart phone

Disqualifiers

Patients planned to undergo total abdominal hysterectomy and bilateral salpingo oophorectomy with immediate reconstruction after mastectomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • digital technology-supported education

    Other intervention

    The education will include information about surgical process and care after surgery.

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: mobile applicationExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Anxiety

The Hospital Anxiety and Depression Scale will be used. It is a valid and reliable scale in Turkish. The higher score the higher risk for depression or anxiety. (Change from baseline to 5th, 15th and 30th days will be assessed).

Time frame
Baseline and 30th days
2

Surgical pain

Visual Analogue Scale (VAS): It is used to evaluate the subjective discomfort states of patients. It consists of a horizontal line 10 cm long. It is a ruler with the left side stating "no pain" and the right side stating "the worst pain" (unbearable pain). Values range from 0 to 10, with higher values indicating increased discomfort. It is easy to apply. It has been shown to be sensitive to pain and discomfort.

Time frame
(Change from baseline to 5th, 15th and 30th days will be assessed).
3

Sleep quality

Pittsburg Sleep Quality Index: It is valid and reliable scale. in Turkish language.The scale consists of 24 questions, 19 of which are feedback questions and 5 of which are to be answered by the spouse or roommate. When calculating the index score, questions answered by the individual's spouse or roommate are not included in the calculation. Self-assessment questions include various items related to sleep quality. These are to determine sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems. The 18 items scored are grouped into 7 component scores. Some of the components consist of a single substance, while others are obtained by grouping several substances. Each item is evaluated with a score between 0-3. The sum of these seven component scores gives the total index score. Total score is between 0-21. A high total score indicates poor sleep quality.

Time frame
(Change from baseline to 5th, 15th and 30th days will be assessed).
4

Quality of life after surgery

SF-12 Quality of Life Scale (SF-12), is a scale that evaluates the quality of life for the last four weeks without focusing on a specific age group or disease group. High scores indicate good health status.

Time frame
(Change from baseline to 5th, 15th and 30th days will be assessed).

Secondary outcomes

Other outcomes

Sponsors and contacts

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