Clinical trial NCT06799507: The Effect of Mindfulness-Based Lifestyle Support Program on Infertile Women
Official title: The Effect of Mindfulness-Based Lifestyle Support Program on Quality of Life, Lifestyle, Mindfulness Level and Treatment Outcomes in Infertile Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fertility Disorders
Infertility (IVF Patients)
Keywords: Infertility
Mindfulness
Quality of Life
Life Style
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled trial aimed to determine whether a mindfulness-based lifestyle support program would improve quality of life, lifestyle, mindfulness, attention and meditation level and treatment outcomes in women undergoing IVF treatment.

Detailed description: Having a diagnosis of infertility is often perceived by individuals as a physically and psychologically challenging experience. At every step of infertility treatment, women face different levels of anxiety and stress. In this direction, recent studies have emphasized the importance of acquiring fertility-supportive lifestyle behaviors, especially to eliminate infertility risk factors. It is stated that positive changes in lifestyle behaviors can positively affect treatment outcomes and quality of life. Recently, awareness-based interventions to support psychological well-being and healthy life behaviors in couples undergoing fertility treatment have gained importance in the literature. There are many psychosocial variables that can affect individuals' perception of quality of life in coping strategies of psychological interventions such as mindfulness. The reason for this is the acquisition of coping skills with more use of mindfulness skills. With the mindfulness approach, infertile women are encouraged to be open to encountering painful situations in the treatment process at any time, not to approach their pain judgmentally, and to see their experiences in the treatment process as a part of humanity. As a result, quality of life can improve by being aware of their body, emotions and thoughts.

The quality of life and lifestyle habits of women receiving fertility support are generally not a factor that is highly evaluated by health professionals. Clinical practice focuses more on medical procedures. However, in addition to medical care, psychological interventions that can support success should also be included in this treatment. Providing healthy lifestyle changes that can reduce stress and increase fertility and support fertility is very useful and necessary for public health.

It is thought that the "Mindfulness-Based Lifestyle Support Program" developed by the researchers and prepared in accordance with adult education principles will be effective in regulating the psychological well-being, quality of life and lifestyle of women receiving in vitro fertilization treatment with fertility-supportive lifestyle trainings and mindfulness practices, and will be effective in achieving more successful treatment results by positively affecting reproductive organs and hormonal balance. In addition, in order to see the effects of this mindfulness-based program more quantitatively, it is planned to follow up the women with wearable technology that gives subjective feedback on brain activities, attention and meditation levels.

The aim of this study is to evaluate the quality of life, lifestyle, mindfulness, attention and meditation levels and treatment outcomes of women receiving in vitro fertilization treatment with fertility-supportive lifestyle education in the "Mindfulness-Based Lifestyle Support Program", which was developed by the researchers as a hybrid and prepared in accordance with adult education principles, in a randomized controlled trial.

The research will be conducted as "hybrid education" face-to-face and online via zoom platform with women who apply to a university hospital IVF Center in Izmir for in vitro fertilization treatment and meet the sampling criteria reached by the researcher. In the study, infertile women will be randomized and divided into 2 groups as intervention and control. The intervention group will receive Mindfulness-based lifestyle support program, while the control group will not be subjected to any training and will receive routine clinical care. The effects of the Mindfulness-based lifestyle support program on infertile women's quality of life, lifestyle, mindfulness level, and treatment outcomes will be evaluated with scales and prepared forms, and the level of attention and meditation will be evaluated with the NeuroSky Mindwave device.

Eligibility criteria: Inclusion Criteria:

* Primary infertility,
* Going to undergo IVF treatment,
* Under 45 years of age,
* Having a smart phone or computer

Exclusion Criteria:

* Participate in any program related to mindfulness
* Prior mindfulness training
* Knowing/doing mindfulness practices beforehand
* Having any psychiatric disorder
* Having any chronic disease
* Disability (hearing/vision etc.)
* Attending less than 80% of the trainings (missing more than 2 Mindfulness trainings)
* Conception during research

Primary outcomes:
measure: The Fertility Quality of Life
timeFrame: through study completion, average 28 days
measure: Fertility Healthy Lifestyle
timeFrame: through study completion, average 28 days
Secondary outcomes:
measure: Mindfulness
timeFrame: through study completion, average 28 days
measure: Attention and Meditation Level
timeFrame: through study completion, average 28 days
measure: Treatment Outcome-Number of Embryos
timeFrame: through study completion, average 28 day
measure: Treatment Outcome-Pregnancy Rate
timeFrame: after study completion, average 10-12 day
measure: Education Program Satisfaction
timeFrame: through study completion, average 28 days
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
References: