Stress Reduction During In Vitro Fertilization

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Behavioral: Healing Touch; Behavioral: Desensitization Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Healing Touch
Experimental: 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.	Behavioral: Desensitization Therapy
No Intervention: Standard Care; Subjects in this arm will receive no therapeutic intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Spielberger State Trait Anxiety Inventory	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Perceived Stress Scale	30 days
Infertility Self-Efficacy Scale	30 days
Pregnancy outcome	30 days

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Kathy Turner RN, NP, Stanford University

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: November 6, 2008
• First Submitted That Met QC Criteria: November 10, 2008
• First Posted (Estimate): November 11, 2008

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: SU-11052008-1334; 15402 (Stanford University IRB)