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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided Imagery | Experimental | Guided Imagery With Audio Media |
|
| Routine Postoperative Care | No Intervention | Subjects will receive routine pre-operative, intra-operative, post-operative, chemotherapy, and radiation care as dictated by pathologic diagnosis. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided Imagery With Audio Media | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of distress in the immediate postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument. | 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. | 6-8 week postoperative exam |
| Measure | Description | Time Frame |
|---|---|---|
| Level of distress, measured by questionnaire using the Hospital Anxiety and Depression Scale-total (HADS-T). | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandy Michaels, MD | University of Michigan | Principal Investigator |
| J. Rebecca Liu, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D014594 | Uterine Neoplasms |
| D010051 | Ovarian Neoplasms |
| D014565 | Urogenital Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
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| ID | Term |
|---|---|
| D019018 | Imagery, Psychotherapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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|
| 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 | postoperative day 1 and 6-8 week postoperative exam |
| Perioperative analgesic use, measured by patient-completed usage log and hospital medical record. | 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. | 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. | 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. | 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. | postoperative day 1 and 6-8 week postoperative exam |
| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D052801 | Male Urogenital Diseases |
| D005184 | Fallopian Tube Diseases |
| D004191 |
| Behavioral Disciplines and Activities |