NCT00788502

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

2.8 years

First QC Date

November 6, 2008

Last Update Submit

June 7, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Spielberger State Trait Anxiety Inventory

    30 days

Secondary Outcomes (3)

  • Perceived Stress Scale

    30 days

  • Infertility Self-Efficacy Scale

    30 days

  • Pregnancy outcome

    30 days

Study Arms (3)

Healing Touch

EXPERIMENTAL

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

Desensitization Therapy

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

Subjects in this arm will receive no therapeutic intervention.

Interventions

Healing TouchBEHAVIORAL
Healing Touch
Desensitization Therapy

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

TouchDesensitization, Psychologic

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

SensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Kathy Turner RN, NP

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2008

First Posted

November 11, 2008

Study Start

October 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

June 9, 2022

Record last verified: 2022-06

Locations