Applied Relaxation for Vasomotor Symptoms

Menopause Clinical Trial

Official title:

Applied Relaxation for Vasomotor Symptoms in Postmenopausal Women - a Randomized, Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01488864
• Other study ID #: LiÖ/AR-2007
• Status: Terminated
• Phase: N/A
• First received: December 6, 2011
• Last updated: May 10, 2012
• Start date: March 2007
• Est. completion date: September 2010

Study information

• Verified date: May 2012
• Source: Ostergotland County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The objectives of this study are to compare frequency and severity of moderate to severe vasomotor symptoms in postmenopausal women treated with applied relaxation (AR) with an untreated control-group (CG) and to investigate if Health Related Quality of Life improve in the AR-group compared to an untreated CG.To study if salivary cortisol excretion would change within the AR treated group compared with the control group.

Description:

Approximately 70% of women in Europe and North America experience hot flashes and night sweats during the climacteric period. Many women abstain from hormonal therapy because of side effects or contraindications such as breast cancer or thrombosis.

Different alternative therapies for alleviation of hot flashes are described in the literature. Both pharmacological treatments, different types of natural remedies, acupuncture, life-style changes and mind-body therapies are suggested as promising therapies. Applied relaxation (AR) is a technique influenced on cognitive behavioral therapy (CBT) using coping mechanism and conditioning. Previous study with healthy postmenopausal women showed promising results on hot flash frequency with an average decrease of more than 70 % with persisting effect three months after therapy and also HRQoL significantly increased probably due to better sleep and diminished vasomotor symptoms. But the method must be further investigated before strong evidence-based conclusion can be drawn.

Cortisol is a potent stress hormone regulated by the hypothalamic-pituitary axis. The factors underlying how alternative treatment works and the mechanism underlying improvements in symptoms are not fully understood.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• postmenopausal women (at least 12 months since last menstrual bleeding occurred or in previously hysterectomised women a serum follicle-stimulating hormone (S-FSH) defined as postmenopausal level according to references at the local laboratory)

• More or equal to 7 moderate to severe hot flashes or more or equal at 50 hot flashes per week according to a two-week screening diary

• ability to understand and speak Swedish

• freely given informed consent

Exclusion Criteria:

• unstable thyroid or other metabolic disease

• treatment with hormone therapy (HT) or other complementary- or alternative treatments treatment for menopausal-related symptoms

• treatment with psychopharmacological drugs and/or sedatives d-un-treated psychiatric disease

• frequently exercising women (= 2h high-intensity activities/week)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

Intervention

Behavioral:
• Applied Relaxation (AR)
AR is a technique influenced on cognitive behavioral therapy using coping mechanism and conditioning. AR focuses on muscle relaxation, where breathing is used for the conditioning of the relaxation. AR implies participation in 10 group sessions during a period of 12 weeks. A therapist will see the women assigned to AR in a group consisted of 6-8 women. The weekly sessions will last for 60 minutes each and are based on a scheme from Öst. The women will be told to practice each component daily. During the first session a lecture about menopause and about theories of the mechanisms behind hot flashes will be given. The aim of applying AR in view of coping with vasomotor symptoms will be discussed. The group is given a rationale of applying AR as a coping technique for handling sudden unanticipated symptoms by quick calming down, and thus gaining control over the situation.

Locations

Country	Name	City	State
Sweden	University Hospital, Dept of Obstetrics and Gynecology	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Elizabeth Nedstrand

Country where clinical trial is conducted

Sweden, 

References & Publications (17)

Aardal E, Holm AC. Cortisol in saliva--reference ranges and relation to cortisol in serum. Eur J Clin Chem Clin Biochem. 1995 Dec;33(12):927-32. — View Citation

Hoffmann M, Hammar M, Kjellgren KI, Lindh-Astrand L, Brynhildsen J. Changes in women's attitudes towards and use of hormone therapy after HERS and WHI. Maturitas. 2005 Sep 16;52(1):11-7. — View Citation

Hunter M. The women's health Questionnaire: a meassure of mid-aged women's perceptions on their emotional and physical health. Psycol Health 7: 45-54, 1992

Hunter MS, Coventry S, Hamed H, Fentiman I, Grunfeld EA. Evaluation of a group cognitive behavioural intervention for women suffering from menopausal symptoms following breast cancer treatment. Psychooncology. 2009 May;18(5):560-3. doi: 10.1002/pon.1414. — View Citation

Hunter MS, Mann E. A cognitive model of menopausal hot flushes and night sweats. J Psychosom Res. 2010 Nov;69(5):491-501. doi: 10.1016/j.jpsychores.2010.04.005. Epub 2010 Jun 1. — View Citation

Innes KE, Selfe TK, Vishnu A. Mind-body therapies for menopausal symptoms: a systematic review. Maturitas. 2010 Jun;66(2):135-49. doi: 10.1016/j.maturitas.2010.01.016. Epub 2010 Feb 18. Review. — View Citation

Lee MS, Shin BC, Ernst E. Acupuncture for treating menopausal hot flushes: a systematic review. Climacteric. 2009 Feb;12(1):16-25. doi: 10.1080/13697130802566980. Review. — View Citation

Lethaby AE, Brown J, Marjoribanks J, Kronenberg F, Roberts H, Eden J. Phytoestrogens for vasomotor menopausal symptoms. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001395. Review. Update in: Cochrane Database Syst Rev. 2013;12:CD001395. — View Citation

Nedstrand E, Wijma K, Lindgren M, Hammar M. The relationship between stress-coping and vasomotor symptoms in postmenopausal women. Maturitas. 1998 Nov 30;31(1):29-34. — View Citation

Nedstrand E, Wijma K, Wyon Y, Hammar M. Applied relaxation and oral estradiol treatment of vasomotor symptoms in postmenopausal women. Maturitas. 2005 Jun 16;51(2):154-62. — View Citation

Nedstrand E, Wijma K, Wyon Y, Hammar M. Vasomotor symptoms decrease in women with breast cancer randomized to treatment with applied relaxation or electro-acupuncture: a preliminary study. Climacteric. 2005 Sep;8(3):243-50. — View Citation

Nelson HD, Vesco KK, Haney E, Fu R, Nedrow A, Miller J, Nicolaidis C, Walker M, Humphrey L. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA. 2006 May 3;295(17):2057-71. Review. — View Citation

Ost LG. Applied relaxation: description of a coping technique and review of controlled studies. Behav Res Ther. 1987;25(5):397-409. Review. — View Citation

Speroff L, Gass M, Constantine G, Olivier S; Study 315 Investigators. Efficacy and tolerability of desvenlafaxine succinate treatment for menopausal vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):77-87. doi: 10.1097/01.AOG.0000297371.89129.b3. — View Citation

Vegter S, Kölling P, Töben M, Visser ST, de Jong-van den Berg LT. Replacing hormone therapy--is the decline in prescribing sustained, and are nonhormonal drugs substituted? Menopause. 2009 Mar-Apr;16(2):329-35. doi: 10.1097/gme.0b013e31818c046b. — View Citation

Wiklund I, Karlberg J, Lindgren R, Sandin K, Mattsson LA. A Swedish version of the Women's Health Questionnaire. A measure of postmenopausal complaints. Acta Obstet Gynecol Scand. 1993 Nov;72(8):648-55. — View Citation

Wyon Y, Wijma K, Nedstrand E, Hammar M. A comparison of acupuncture and oral estradiol treatment of vasomotor symptoms in postmenopausal women. Climacteric. 2004 Jun;7(2):153-64. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hot flashes average number and severity	The average number and severity of hot flashes/24 hours in self-registered diaries during the 12th week	Baseline to 12 week after "start of treatment"	No
Secondary	Hot flashes	The average number and severity of hot flashes per 24 hours after 3 months follow-up.	Baseline to 3 months after "end of treatment"	No
Secondary	Hot flashes reduction of hot flashes	The reduction of hot flashes in women defined as responders. Responders are defined as women with =50% reduction of hot flashes.	Baseline to 3 months after "end of treatment"	No
Secondary	Health Related Quality of Life	The total score in the Women Health Questionnaire measured at 12th week and after 3 months follow-up.	Baseline to 3 months "end of treatment"	No
Secondary	Adverse Events	Adverse events documented by means of using open-ended questions at each contact.	Baseline to 3 months "end of treatment"	Yes
Secondary	Salivary cortisol	Three samples of salivary cortisol (at awakening, 30 minutes after awakening, and at bedtime)were collected at baseline, after 12 weeks and 3 months after "end-of-treatment"	Baseline to 3 months after "end-of-treatment"	No