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Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial

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ClinicalTrials.gov Identifier: NCT01293695
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : September 17, 2015
Last Update Posted : August 16, 2016
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Gary R. Elkins, Baylor University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Hot Flashes
Interventions: Behavioral: Hypnosis
Other: Structured attention

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred from December, 2008 to April, 2012. Participants were recruited by using fliers, mailings, billboard advertising and word-of-mouth. Local clinics were also visited and informative materials were left with physicians.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hypnosis

Receives 5 weeks of hypnotic relaxation therapy

Hypnosis: Hypnosis relaxation in five weekly sessions

Structured Attention

Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy

Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis


Participant Flow:   Overall Study
    Hypnosis   Structured Attention
STARTED   93   94 
COMPLETED   78   87 
NOT COMPLETED   15   7 
Withdrawal by Subject                7                1 
Lost to Follow-up                8                6 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Hypnosis

Receives 5 weeks of hypnotic relaxation therapy (HRT)

Hypnosis: Hypnosis relaxation in five weekly sessions

Structured Attention

Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy

Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis

Total Total of all reporting groups

Baseline Measures
   Hypnosis   Structured Attention   Total 
Overall Participants Analyzed 
[Units: Participants]
 93   94   187 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   84   87   171 
>=65 years   9   7   16 
Gender 
[Units: Participants]
     
Female   93   94   187 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian   2   3   5 
Asian   1   0   1 
African American   20   11   31 
Hispanic   6   6   12 
White   64   74   138 
Region of Enrollment 
[Units: Participants]
     
United States   93   94   187 
Marital Status 
[Units: Participants]
     
Married   57   65   122 
Divorced   8   10   18 
Separated   5   5   10 
Single   19   12   31 
Widowed   4   2   6 
Education 
[Units: Participants]
     
Less than High School   10   6   16 
High School Diploma   26   26   52 
College, non degree   20   20   40 
Associate Degree   12   12   24 
Bachelor's Degree   14   22   36 
Graduate Degree   11   8   19 
Hot Flash Frequency [1] 
[Units: Hot flashes per week]
Mean (Standard Deviation)
 75.26  (2.82)   75.21  (3.11)   75.24  (2.97) 
Hot Flash Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 24.43  (1.02)   22.94  (1.23)   23.69  (1.13) 
Biolog Hot Flash Monitor (physiological measure) [1] 
[Units: Micro Siemens]
Mean (Standard Deviation)
 10.41  (1)   8.85  (.75)   9.63  (.88) 
Hot Flash Related Daily Interference Scale (HFRDIS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.87  (.23)   5.75  (.24)   5.81  (24) 
Pittsburg Sleep Quality Index (PSQI) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 11.69  (.56)   11.89  (.48)   11.79  (.52) 


  Outcome Measures

1.  Primary:   Hot Flash Frequency   [ Time Frame: 6 Weeks and 12 Weeks ]

2.  Primary:   Hot Flash Score   [ Time Frame: 6 Weeks and 12 Weeks ]

3.  Primary:   Hot Flash Related Daily Interference Scale (HFRDIS)   [ Time Frame: 6 Weeks and 12 Weeks ]

4.  Secondary:   Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture   [ Time Frame: 6 Weeks and 12 Weeks ]

5.  Secondary:   Pittsburg Sleep Quality Index (PSQI)   [ Time Frame: 6 Weeks and 12 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

limitations: results may not generalize to all women with hot flashes

  • some hot flashes occur at other times than during the climacteric
  • self-selection bias (predispositions to mind-body therapy)
  • population was largely caucasian


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Gary Elkins, Director of the Mind-Body Medicine Research Laboratory
Organization: Baylor University
phone: 254-296-0643
e-mail: gary_elkins@baylor.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gary R. Elkins, Baylor University
ClinicalTrials.gov Identifier: NCT01293695     History of Changes
Other Study ID Numbers: 194610
5U01AT004634 ( U.S. NIH Grant/Contract )
First Submitted: February 10, 2011
First Posted: February 11, 2011
Results First Submitted: January 28, 2015
Results First Posted: September 17, 2015
Last Update Posted: August 16, 2016