Stress Reduction During In Vitro Fertilization

Infertility Clinical Trial

Official title:

Stress Reduction During In Vitro Fertilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788502
• Other study ID #: SU-11052008-1334
• Secondary ID: 15402
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Est. completion date: August 2011

Study information

• Verified date: June 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Behavioral:
• Healing Touch

• Desensitization Therapy

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spielberger State Trait Anxiety Inventory		30 days
Secondary	Perceived Stress Scale		30 days
Secondary	Infertility Self-Efficacy Scale		30 days
Secondary	Pregnancy outcome		30 days