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NCT Number: NCT02444195

Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients

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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Key information

Conditions

Uterine Cervical Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Self-Administered Guided Imagery in the Perioperative Period to Reduce Postoperative Distress in Gynecologic Oncology Patients: A Randomized Control Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 14, 2015
Registry last updated
Mar 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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