Stress Reduction During In Vitro Fertilization
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healing Touch
Desensitization Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:-Age <43
- FSH <= 14
- About to enter an IVF cycle at the Stanford Fertility and Reproductive Medicine Center
- Planning a transfer of their own fresh embryos during this cycle
- Speak and read English fluently
- Not planning to use concomitant energy work interventions (HT, Reiki, QiGong, acupuncture)during the IVF cycle.
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Healing Touch
Desensitization Therapy
Standard Care
Arm Description
Healing Touch (HT) is a gentle form of energy balancing work that promotes relaxation. Subjects in this arm will receive three one-hour sessions of Healing Touch during the first two weeks of their IVF cycle.
Desensitization Therapy is a quasi-desensitization procedure where subjects meet with a therapist and generate a list of stressful thoughts and a list of neutral thoughts. Subjects in this arm will receive three one-hour sessions of Desensitization Therapy during the first two weeks of their IVF cycle.
Subjects in this arm will receive no therapeutic intervention.
Outcomes
Primary Outcome Measures
Spielberger State Trait Anxiety Inventory
Secondary Outcome Measures
Perceived Stress Scale
Infertility Self-Efficacy Scale
Pregnancy outcome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00788502
Brief Title
Stress Reduction During In Vitro Fertilization
Official Title
Stress Reduction During In Vitro Fertilization
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to determine the effect of Healing Touch (HT) on the stress, anxiety, and self-efficacy experiences of women undergoing in vitro fertilization (IVF) in a randomized, controlled design. HT is a gentle, non-invasive form of energy-balancing work that promotes relaxation.
Detailed Description
Once enrolled, each participant will be randomized to one of three groups: the Healing Touch (HT) treatment arm, the Desensitization Therapy (DT) arm, or the no-intervention arm.
Subjects in Group 1 will receive three, 45-minute HT sessions during the first two weeks of their IVF cycle prior to oocyte retrieval. Group 2 will receive three, 45-minute DT sessions during the first two weeks of their IVF cycle prior to oocyte retrieval. Group 3 will receive no intervention. Subjects in Group 3 will be offered two HT sessions after completing study participation.
All subjects and their partners will be asked to complete the Spielberger State Trait Anxiety Inventory (STAI), the Perceived Stress Scale (PSS) and the Infertility Self-Efficacy Scale (ISES) at three time points: 1) baseline 2) one day prior to oocyte retrieval and 3) 5-7 days post embryo transfer. In addition, subjects in all groups will complete a short pre-study questionnaire to assess expectation of therapeutic effect, and subjects in the two intervention groups will complete a short post-study questionnaire to evaluate their treatment experience. Demographic and pregnancy outcome data will be collected for all subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healing Touch
Arm Type
Experimental
Arm Description
Healing Touch (HT) is a gentle form of energy balancing work that promotes relaxation. Subjects in this arm will receive three one-hour sessions of Healing Touch during the first two weeks of their IVF cycle.
Arm Title
Desensitization Therapy
Arm Type
Experimental
Arm Description
Desensitization Therapy is a quasi-desensitization procedure where subjects meet with a therapist and generate a list of stressful thoughts and a list of neutral thoughts. Subjects in this arm will receive three one-hour sessions of Desensitization Therapy during the first two weeks of their IVF cycle.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Subjects in this arm will receive no therapeutic intervention.
Intervention Type
Behavioral
Intervention Name(s)
Healing Touch
Intervention Type
Behavioral
Intervention Name(s)
Desensitization Therapy
Primary Outcome Measure Information:
Title
Spielberger State Trait Anxiety Inventory
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Perceived Stress Scale
Time Frame
30 days
Title
Infertility Self-Efficacy Scale
Time Frame
30 days
Title
Pregnancy outcome
Time Frame
30 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:-Age <43
FSH <= 14
About to enter an IVF cycle at the Stanford Fertility and Reproductive Medicine Center
Planning a transfer of their own fresh embryos during this cycle
Speak and read English fluently
Not planning to use concomitant energy work interventions (HT, Reiki, QiGong, acupuncture)during the IVF cycle.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy Turner RN, NP
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stress Reduction During In Vitro Fertilization
We'll reach out to this number within 24 hrs