Stress Reduction During In Vitro Fertilization

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Behavioral: Healing Touch; Behavioral: Desensitization Therapy

• Registration Number: NCT00788502
• Lead Sponsor: Stanford University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-06
• Study First Submitted QC: 2008-11-10
• Study First Posted: 2008-11-11
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healing Touch	Healing Touch	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	Desensitization Therapy	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.

Primary Outcome Measures

Name	Time	Method
Spielberger State Trait Anxiety Inventory	30 days

Secondary Outcome Measures

Name	Time	Method
Infertility Self-Efficacy Scale	30 days
Pregnancy outcome	30 days
Perceived Stress Scale	30 days

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States