Applied Relaxation for Vasomotor Symptoms

NCT01488864 | Terminated

• 1 other identifier: LiÖ/AR-2007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause; Hot Flashes

Keywords

Hot flashes; Vasomotor symptoms; Menopause; Applied Relaxation; Health Related Quality of Life; Salivary cortisol

Outcome Measures

Primary Outcomes (1)

• 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"

Secondary Outcomes (5)

• Hot flashes

  Baseline to 3 months after "end of treatment"

• Hot flashes reduction of hot flashes

  Baseline to 3 months after "end of treatment"

• Health Related Quality of Life

  Baseline to 3 months "end of treatment"

• Adverse Events

  Baseline to 3 months "end of treatment"

• Salivary cortisol

  Baseline to 3 months after "end-of-treatment"

Study Arms (2)

Applied Relaxation (AR)

EXPERIMENTAL

Behavioral: Applied Relaxation (AR)

Untreated Control Group (CG)

NO INTERVENTION

The women assigned to CG will be told to act as an untreated control group i.e. not to use hormonal treatment, other alternative medication, natural remedies for hot flashes and even not acupuncture, mind-body therapies or intensive physical activity.

Interventions

Applied Relaxation (AR) BEHAVIORAL

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.

Applied Relaxation (AR)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Elizabeth Nedstrand: lead

Study Sites (1)

University Hospital, Dept of Obstetrics and Gynecology

Linköping, 5851 85, Sweden

Location

Related Publications (18)

• 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. doi: 10.1016/s0378-5122(98)00058-9.

  PMID: 10091202 BACKGROUND

• 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. doi: 10.1016/j.maturitas.2004.05.017.

  PMID: 15917156 BACKGROUND

• 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. doi: 10.1080/13697130500118050.

  PMID: 16390756 BACKGROUND

• Ost LG. Applied relaxation: description of a coping technique and review of controlled studies. Behav Res Ther. 1987;25(5):397-409. doi: 10.1016/0005-7967(87)90017-9. No abstract available.

  PMID: 3318800 BACKGROUND

• 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.

  PMID: 20955869 BACKGROUND

• 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.

  PMID: 18646246 BACKGROUND

• 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.

  PMID: 20167444 BACKGROUND

• Vegter S, Kolling P, Toben 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.

  PMID: 19188855 BACKGROUND

• 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. doi: 10.1016/j.maturitas.2005.06.003.

  PMID: 16023804 BACKGROUND

• 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. doi: 10.1001/jama.295.17.2057.

  PMID: 16670414 BACKGROUND

• 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. doi: 10.1002/14651858.CD001395.pub3.

  PMID: 17943751 BACKGROUND

• 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. doi: 10.1080/13697130410001713814.

  PMID: 15497904 BACKGROUND

• 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.

  PMID: 19116803 BACKGROUND

• 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.

  PMID: 18165395 BACKGROUND

• 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. doi: 10.3109/00016349309021159.

  PMID: 8259753 BACKGROUND

• 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

  BACKGROUND

• 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. doi: 10.1515/cclm.1995.33.12.927.

  PMID: 8845424 BACKGROUND

• Lindh-Astrand L, Nedstrand E. Effects of applied relaxation on vasomotor symptoms in postmenopausal women: a randomized controlled trial. Menopause. 2013 Apr;20(4):401-8. doi: 10.1097/gme.0b013e318272ce80.

  PMID: 23149867 DERIVED

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth Nedstrand, Md, PhD

  Ostergotland CC, University Hospital Dept. of Obstetrics and Gynecology, 582 85 Linköping, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Md, PhD

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 8, 2011
• Study Start: March 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 11, 2012

Record last verified: 2012-05

Locations

SE (1)