The Effect of Mindfulness-Based Lifestyle Support Program on Infertile Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorDokuz Eylul University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary infertility,

Going to undergo IVF treatment,

Under 45 years of age,

Having a smart phone or computer

Disqualifiers

Participate in any program related to mindfulness

Prior mindfulness training

Knowing/doing mindfulness practices beforehand

Having any psychiatric disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Interventions Based on Mindfulness

    Behavioral

    Affirmation, Relaxation, Mindfulness, Meditation, Healthy Lifestyle, Quality Life

  • Routine clinical procedure

    Other intervention

    Routine clinical procedure

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The Fertility Quality of Life

Fertility quality of life tool (FertiQoL): This scale is a self-rating questionnaire specifically designed to assess the quality of life of infertile patients. It has good reliability and efficacy in many countries. The Cronbach's α value of the Turkish version of FertiQoL is 0.905. The FertiQoL scale includes two modules: The Core FertiQoL module and the optional Treatment FertiQoL module. The Core FertiQoL module is divided into four domains: emotional (6 items), mind-body (6 items), relationship (6 items) and social (6 items). The optional Treatment FertiQoL module is divided into two domains: environment (6 items) and tolerability of infertility treatment (4 items). Each item has a score of 0-4 points and the total scale and subscale scores can be converted into 0-100 point scales. The higher the scores obtained from the scale, the higher the fertility-related quality of life.

Time frame
through study completion, average 28 days
2

Fertility Healthy Lifestyle

Fertility Healthy Lifestyle Assessment Scale (FHLAS): This is a 46-item scale developed by Bilgiç et al. to assess healthy lifestyles that contribute to improving fertility in women and men. It consists of seven sub-dimensions and is a 5-point Likert-type scale (1-strongly disagree, 2- disagree, 3 undecided, 4- agree, and 5-strongly agree). The seven sub-dimensions of the scale are emotional well-being, physical activity, sleep, nutrition, technology, hygiene and spirituality. Cronbach's Alpha value of the scale was found to be 0.87. The lowest score obtained from the scale is 46 and the highest score is 230. High scores obtained from the total scale and its sub-dimensions indicate that individuals have a lifestyle associated with healthier fertility.

Time frame
through study completion, average 28 days

Secondary outcomes

1

Mindfulness

Mindful Attention Awareness Scale (MAAS): aims to determine the general tendency to be aware of and attentive to momentary experiences in daily life. The 6-point Likert-type scale consists of 15 items and one dimension. As a result of the reliability analysis, the Cronbach Alpha internal consistency coefficient of the scale was calculated as .80 and the test-retest correlation was calculated as .86. High scores on the scale indicate high levels of mindfulness.

Time frame
through study completion, average 28 days
2

Attention and Meditation Level

NeuroSky Mindwave: The device will be implemented by the researcher. This wearable EEG device was developed as a direct biosensor to detect attention and meditation states by reading the electrical activity of the brain. The device features dry active technology, without the need for gel. The two metal parts of the ear clip are attached in contact with the earlobe and the sensor part is adjusted to contact the forehead above the left eye. With the help of the sensors, Attention and Meditation levels of the brain can be calculated. Measurement of the level of Mindfulness and Meditation will be obtained for both the intervention and the control group. In order to obtain a healthy signal with the device, there should be no elements such as hair, dead skin or makeup to prevent contact.

Time frame
through study completion, average 28 days
3

Treatment Outcome-Number of Embryos

The number of embryos, which is one of the treatment outcomes of women who completed the Mindfulness-Based Lifestyle Support Program, will be recorded in the "Treatment Outcome Form" created by the researchers. The information in the relevant form will be recorded by the researcher after the oocyte retrieval process by interviewing the women and looking at the system records.

Time frame
through study completion, average 28 day
4

Treatment Outcome-Pregnancy Rate

The pregnancy rate, which is one of the treatment outcomes of women who completed the Mindfulness-Based Lifestyle Support Program, will be recorded on the "Treatment Outcome Form" created by the researchers. The information in the relevant form will be recorded by the researcher by interviewing the women and checking the system records after the pregnancy test procedure performed approximately 10-12 days after the embryo transfer procedure.

Time frame
after study completion, average 10-12 day

Other outcomes

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