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Life-Stress Interview for Women With Chronic Urogenital Pain Conditions

NCT ID: NCT02286115

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-01-31

Brief Summary

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The goal of this study is to test the efficacy, feasibility, and acceptability of providing an experiential assessment interview that targets health, and emotional and stressful experiences in a tertiary care setting specializing in women's urology.

Detailed Description

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In this randomized, controlled trial, the investigators will compare an interview condition to a wait-list control condition. The investigators hypothesize that helping individuals identify the links between their stress, emotions, and physical symptoms will likely increase their awareness and endorsement of the link between stress and physical symptoms, including a willingness to engage in stress management techniques. It is also expected that helping raise an individual's awareness about their symptoms, followed by an experience and expression of unexpressed emotion is likely to influence their physical and psychological well-being.

Conditions

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Chronic Urogenital Pain

Keywords

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Chronic Pelvic Pain Interstitial Cystitis Vulvodynia Dyspareunia Pelvic Floor Dysfunction Emotional Processing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Life-Stress Interview

The Life-Stress Interview is an experiential assessment technique

Group Type EXPERIMENTAL

Life-Stress Interview

Intervention Type BEHAVIORAL

A life-stress interview which aims to help patients: a) disclose their stressful experiences and emotional conflicts, which might be contributing to their symptoms, b) learn about associations between their stress and physical symptoms; and c) learn about the potential value of experiencing and expressing their emotions related to these stressful situations

Wait-list Control

Wait-list Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Life-Stress Interview

A life-stress interview which aims to help patients: a) disclose their stressful experiences and emotional conflicts, which might be contributing to their symptoms, b) learn about associations between their stress and physical symptoms; and c) learn about the potential value of experiencing and expressing their emotions related to these stressful situations

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Participants must have a chronic urogenital pain condition

Exclusion Criteria

* non-English speaking
* unable to read
* psychosis
* dementia
* mental impairment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wayne State University

OTHER

Sponsor Role collaborator

William Beaumont Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Carty, M.A.

Role: PRINCIPAL_INVESTIGATOR

Beaumont Health Systems and Wayne State University

Mark A Lumley, PhD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

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Women's Urology Center

Royal Oak, Michigan, United States

Site Status

Countries

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United States

References

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Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.

Reference Type DERIVED
PMID: 32734597 (View on PubMed)

Other Identifiers

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HIC.2014-151

Identifier Type: -

Identifier Source: org_study_id