The Effect of a Four-Week Hatha Yoga Intervention to Improve Quality of Life, Anxiety, and Depressive Symptoms in Individuals Undergoing Assisted Reproductive Technology (ART) Treatment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorVillanova University

About this trial

The goal of this clinical trial is to learn if a four-week yoga program works to improve quality of life in people undergoing IVF (In Vitro Fertilization). It will also learn if a four-week yoga program decreases anxiety and depression symptoms in people undergoing IVF.

The main questions it aims to answer are:

* Does a four-week yoga program effect quality of life, anxiety, and depression symptoms in people undergoing IVF? * Do the effects vary by individual characteristics of the people in the study?

Researchers will compare the yoga intervention group to routine care as usual.

Participants will:

* Participate in a weekly virtual yoga class for four weeks (total of four yoga classes), or follow routine care as usual while undergoing IVF. * Take three online surveys every 4 weeks. * Be involved in the study for 8 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older

Understand English

Scheduled for or currently undergoing an IVF cycle

Access to smartphone/computer/tablet and internet

Disqualifiers

Individuals who are Pregnant, or who become Pregnant during the study

Individuals undergoing non-IVF cycles (i.e. intrauterine insemination)

Individuals undergoing a frozen embryo transfer (FET) cycle

Individuals who are currently regularly practicing yoga

Trial design

Design model

Crossover

Treatments tested in this trial

  • Yoga

    Behavioral

    The intervention in this study is a four-week Hatha yoga intervention delivered virtually.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Wait-List Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Fertility Quality of Life using the FertiQoL, a validated 24-item self-report questionnaire, measured at 4 weeks and 8 weeks.

The change in Fertility Quality of Life will be measured using the Fertility Quality of Life scale (FertiQoL), a validated 24-item self-report questionnaire that assesses fertility quality of life, with total scores ranging from 0 to 100. Higher scores mean higher quality of life. Change in FertiQoL will be measured between the intervention group and wait-list control group at baseline, 4 weeks, and 8 weeks.

Time frame
From enrollment (Baseline) to the end of treatment at 8 weeks.
2

Change from Baseline in Anxiety symptom severity using the Hospital Anxiety and Depression Scale, Anxiety Subscale (HADS-A), measured at 4 weeks and 8 weeks.

The change in Anxiety symptom severity will be measured using the Hospital Anxiety and Depression Scale, Anxiety Subscale (HADS-A), a validated 7-item questionnaire with scores ranging from 0 to 21, where higher scores indicate greater anxiety severity. Change in HADS-A will be measured between the intervention group and wait-list control group at baseline, 4 weeks, and 8 weeks.

Time frame
From enrollment (Baseline) to the end of treatment at 8 weeks.
3

Change from Baseline in Depressive symptom severity using the Patient Health Questionnaire (PHQ-9), measured at 4 weeks and 8 weeks.

The change in Depressive symptom severity will be measured using the Patient Health Questionnaire (PHQ-9), a validated 9-item questionnaire with scores ranging from 0 to 27, where higher scores indicate greater depressive symptom severity. Change in PHQ-9 will be measured between the intervention group and wait-list control group at baseline, 4 weeks, and 8 weeks.

Time frame
From enrollment (Baseline) to the end of treatment at 8 weeks.

Secondary outcomes

1

Determine if intervention effectiveness differs by individual characteristics, considering in-group differences in baseline characteristics and clinical information.

Multivariate regression analysis will be conducted to identify any independent association between baseline characteristics and changes in scores. The equivalence of groups at baseline will be checked to control for differences if needed. Univariate descriptive statistics (distribution, measures of central tendency, and variability) will summarize baseline data.

Time frame
From enrollment to the end of treatment at 8 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Villanova University

Lead sponsor

American Society for Reproductive Medicine

Collaborator

This trial is not recruiting at the moment. You can still explore other options: