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Trial record 3 of 64 for:    Completed Studies | guided imagery

Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients

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ClinicalTrials.gov Identifier: NCT02444195
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the effectiveness of self-administered perioperative guided imagery to reduce perioperative distress in gynecologic oncology patients undergoing surgical management for a presumed cancer diagnosis.

Condition or disease Intervention/treatment
Uterine Cervical Neoplasms Uterine Neoplasms Ovarian Neoplasms Urogenital Neoplasms Fallopian Tube Neoplasms Behavioral: Guided Imagery With Audio Media

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Self-Administered Guided Imagery in the Perioperative Period to Reduce Postoperative Distress in Gynecologic Oncology Patients: A Randomized Control Trial
Study Start Date : April 2015
Primary Completion Date : May 1, 2016
Study Completion Date : May 1, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Guided Imagery
Guided Imagery With Audio Media
Behavioral: Guided Imagery With Audio Media
Subjects assigned to the experimental arm will be asked to participate in meditation daily using the audio media provided for the 7 days prior to surgery, in the preoperative holding area, for the 7 days following surgery, and are encouraged to engage in affirmations module use at least weekly in the 6-8 week postoperative period.
No Intervention: Routine Postoperative Care
Subjects will receive routine pre-operative, intra-operative, post-operative, chemotherapy, and radiation care as dictated by pathologic diagnosis.


Outcome Measures

Primary Outcome Measures :
  1. Level of distress in the immediate postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument. [ Time Frame: postoperative day 1 ]
  2. Level of distress in the delayed postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument. [ Time Frame: 6-8 week postoperative exam ]

Secondary Outcome Measures :
  1. Level of distress, measured by questionnaire using the Hospital Anxiety and Depression Scale-total (HADS-T). [ Time Frame: postoperative day 1 and 6-8 week postoperative exam ]
  2. Level of anxiety and depressions, measured by questionnaire using the Hospital Anxiety and Depression Scale subscale for anxiety (HADS-A) and depression (HADS-D). [ Time Frame: postoperative day 1 and 6-8 week postoperative exam ]
  3. Level of pain, measured by a 7-item questionnaire using a Likert numerical rating scale for pain [ Time Frame: postoperative day 1 and 6-8 week postoperative exam ]
  4. Perioperative analgesic use, measured by patient-completed usage log and hospital medical record. [ Time Frame: postoperative day 1 and 6-8 week postoperative exam ]
  5. Patient satisfaction regarding in hospital perioperative care, measured by a questionnaire adapted from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. [ Time Frame: postoperative day 1 and 6-8 week postoperative exam ]
  6. Effect of perioperative guided imagery on health care compliance, measured by the General Adherence Scale (GAS) survey. [ Time Frame: 6-8 week postoperative visit ]
  7. Effect of perioperative guided imagery on health care related locus of control, measured by the Multidimensional Health Locus of Control-form A (MHLC-A) questionnaire. [ Time Frame: postoperative day 1 and 6-8 week postoperative exam ]
  8. The effect of perioperative guided imagery on hope, measured by the Adult Hope Scale (AHS) questionnaire. [ Time Frame: postoperative day 1 and 6-8 week postoperative exam ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing surgical management for a suspected diagnosis of Gynecologic Malignancy (Endometrial, Ovarian, Vulvar, Vaginal, Primary Peritoneal, Fallopian Tube)
  • Age 18 or greater
  • Receiving care at University of Michigan Comprehensive Cancer Center Gynecologic Oncology Clinic or at St. Joseph Mercy Hospital, Alexander Cancer Care Center
  • Able to understand and read English
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Patients must have working telephone, mobile or land line

Exclusion Criteria:

  • Severe hearing impairment that limits the ability to use audio-based guided imagery modules
  • Current documented alcohol abuse or illicit drug substance abuse
  • Planned outpatient surgery
  • Patients currently participating in a meditation practice for more than 1 hour per week prior to preoperative visit.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444195


Locations
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Brandy Michaels, MD University of Michigan
Principal Investigator: J. Rebecca Liu, MD University of Michigan
More Information

Responsible Party: Brandy Michaels, Gynecologic Oncology Fellow, University of Michigan
ClinicalTrials.gov Identifier: NCT02444195     History of Changes
Other Study ID Numbers: HUM00095520
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Brandy Michaels, University of Michigan:
gynecologic cancer
guided imagery
postoperative distress
perioperative distress

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Urogenital Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders
Uterine Cervical Diseases
Uterine Diseases
Fallopian Tube Diseases