An interventional study of Guided Imagery With Audio Media in Uterine Cervical Neoplasms, Uterine Neoplasms and Ovarian Neoplasms, sponsored by University of Michigan. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-20.
Sponsored by University of Michigan · Not applicable, Interventional, and Supportive care
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 130 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Guided Imagery With Audio Media
Behavioral: Guided Imagery With Audio Media
Subjects will receive routine pre-operative, intra-operative, post-operative, chemotherapy, and radiation care as dictated by pathologic diagnosis.
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.
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
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
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
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
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
Perioperative analgesic use, measured by patient-completed usage log and hospital medical record.
Time frame: postoperative day 1 and 6-8 week postoperative exam
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
Effect of perioperative guided imagery on health care compliance, measured by the General Adherence Scale (GAS) survey.
Time frame: 6-8 week postoperative visit
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
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
Plan to share: No
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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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University of Michigan