Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ASRM Nursing/PA Research Award | Other Identifier | American Society for Reproductive Medicine (ASRM) Research Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Society for Reproductive Medicine | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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:
Researchers will compare the yoga intervention group to routine care as usual.
Participants will:
The lifetime prevalence of infertility globally is 17.5%, meaning that one in six people have experienced infertility at some point in their life.When unable to conceive, individuals and couples frequently turn to assisted reproductive technology services. Assisted reproductive technology (ART) treatments provide hope and reproductive opportunities to individuals and couples globally. Yet, ART treatments often cause emotional distress. The emotional and psychosocial distress that individuals undergoing ART care experience is comparable to the emotional experiences of women with cancer and other serious medical conditions. Substantial evidence illustrates the emotional burden of ART care and its negative impact on quality of life. In fact, this relentless emotional stress often causes women to stop ART treatments before achieving pregnancy, demonstrating that emotional factors do impact clinical outcomes.
Individuals in ART care have complex psychosocial needs along with biomedical ones. Because stress is so prominent in ART care and often contributes to discontinuing ART treatment, individuals may benefit from services aimed at reducing stress and anxiety and increasing quality of life. Psychosocial interventions, such as yoga, support the holistic needs of individuals in ART care. While previous studies and systematic reviews indicate that yoga for individuals in ART care is feasible, acceptable, and efficacious, there is a lack of rigorous studies on yoga interventions in ART care.
To address this critical need for health promotion and prevention of psychological distress, we will evaluate a four-week virtually delivered Hatha yoga intervention to support the psychosocial needs of individuals actively undergoing in vitro fertilization (IVF).
IVF is the most common type of ART treatment in the US and globally. Yoga is a mind-body practice, rooted in ancient Indian philosophy, which positively impacts physical and mental health and well-being. Hatha yoga, which is commonly practiced in the United States, incorporates breathing exercises, postures, and meditation.
A RCT with wait-list control group, using mixed effects analysis, will be conducted to achieve the following specific aims. 80 individuals actively undergoing IVF will be recruited for this study. Computer-generated block randomization will allocate 40 participants to the four-week virtually delivered Hatha yoga intervention group, and 40 participants will be allocated to the waitlist control group.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | After randomization, participants in this arm will receive the four-week yoga intervention. |
|
| Wait-List Control Group | Active Comparator | After randomization, participants in this arm will receive routine care as usual for 4 weeks and then will receive the four-week yoga intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga | Behavioral | The intervention in this study is a four-week Hatha yoga intervention delivered virtually. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment (Baseline) to the end of treatment at 8 weeks. |
| 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. | From enrollment (Baseline) to the end of treatment at 8 weeks. |
| 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. | From enrollment (Baseline) to the end of treatment at 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Beth Murray, MEd, BSN, RN | Contact | 484-995-5006 | mmurra45@villanova.edu | |
| Kimberly Trout, PhD, CNM, FACNM, FAAN | Contact | kimberly.trout@villanova.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mary B Murray, MEd, BSN, RN | Villanova University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Villanova University | Villanova | Pennsylvania | 19085 | United States |
Data will be de-identified and is not planned to be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
This study uses a randomized controlled trial (RCT) design with a wait-list control group.
Not provided
Not provided
Not provided
|
| From enrollment to the end of treatment at 8 weeks. |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D000092862 | Psychological Well-Being |
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
| D012919 | Social Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
Not provided
Not provided