Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
108 participants
INTERVENTIONAL
2021-09-03
2022-08-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Music Therapy on Sleep Quality and Depression in Menopausal Women
NCT05545761
Cukurova University Faculty of Medicine Non-interventional Clinical Research Institutional Ethics Committe
NCT05075694
The Effects of Reiki on Menopausal Symptoms and Depression Levels
NCT05977426
Foot Massage for Women With Menopause
NCT05212376
The Effect of Acupressure, Laughter Yoga and Mindfulness on Menopausal Symptoms and Quality of Life
NCT04731402
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Along with the decrease in estrogen during menopause, symptoms related to hot flashes, night sweats, palpitations, irritability and sleep disorders are common. Especially sleep disorders are higher than in the premenopausal period. It has been reported that approximately 40-60% of menopausal women have sleep-related symptoms with night awakenings as the most common complaint. In the study of Lima et al. in which they included 819 climacteric women in Brazil; Deterioration in sleep quality was detected in 67% of the sample, more prominently in postmenopausal women. The most common complaints during menopause are deterioration of sleep quality and chronic insomnia. Untreated sleep disorders and menopausal symptoms adversely affect health and especially reduce quality of life. When the literature is examined, poor sleep quality and insufficient sleep duration; hormonal changes, poor physical health, obesity, cardiovascular disease, diabetes, irritability, physical and mental burnout, and poor quality of life, such as short-term and long-term outcomes. It is stated that the symptoms seen in the menopausal period negatively affect the quality of life of women.
Although the effective treatment to be used to solve the sleep problems experienced during the menopause period, reduce the menopausal symptoms and improve the quality of life is medication or hormonal therapy, the use of non-pharmacological methods is increasing due to the potential side effects of these treatments and the harm outweighing the benefit. Some of these methods are music, yoga, aromatherapy, therapeutic massage, physical exercise, sleep hygiene education, therapeutic touch, acupressure, acupuncture and cognitive behavioral therapy methods.
Therapeutic touch, which is among the non-pharmacological methods that have started to be preferred in recent years, is the interpretation of an ancient healing experience in the modern age. It is a non-invasive nursing intervention that channels energy using the hands. There are no known side effects associated with the use of therapeutic touch. Therapeutic touch is beneficial in reducing anxiety, pain and depression, and increasing relaxation and well-being.Therefore, this calming effect of therapeutic touch also facilitates falling asleep and can improve quality of life by easing menopausal symptoms. Another widely used non-pharmacological method is recital. Perceived calming music lowers catecholamine levels, respiratory rate, heart rate, and blood pressure. Therefore, by roviding physiological and psychological relaxation, music helps individuals to sleep better, reduce menopausal symptoms, and improve quality of life. In a meta analysis study, it was determined that listening to calming music effectively improved sleep quality.
When the literature was examined, no study was found that examined the effects of therapeutic touch and music listening on sleep quality, menopausal symptoms and menopausal quality of life in menopausal women. It is thought that the findings obtained from the research will contribute to the literature. Based on all these, the aim of this study is to examine the effects of therapeutic touch and music listening on sleep quality, menopausal symptoms and quality of life in menopausal women.
Purpose Of The Study The aim of the study was to investigate the effect of therapeutic touch and music listening on sleep quality, menopausal symptoms and quality of life in menopausal women.
Research Hypotheses H10: Therapeutic touch does not affect sleep quality in menopausal women H11: Therapeutic touch affects sleep quality in menopausal women H20: Therapeutic touch does not affect menopausal symptoms in menopausal women H21: Therapeutic touch affects menopausal symptoms in menopausal women H30: Therapeutic touch does not affect quality of life in menopausal women H31: Therapeutic touch affects quality of life in menopausal women H40: Music listening does not affect sleep quality in menopausal women H41: Listening to music affects sleep quality in menopausal women H50: Listening to music does not affect menopausal symptoms in menopausal women H51: Listening to music affects menopausal symptoms in menopausal women H60: Music listening does not affect quality of life in menopausal women H61: Music listening affects quality of life in menopausal women
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
Once a week for four weeks after the preliminary test data Therapeutic Touch Group; Therapeutic Touch application will be performed by the researcher at the appointed time. Each therapeutic touch will take 15 minutes, in accordance with the literature information. At the end of the fourth week, the final test data will be obtained.
Music Listening Group: After the preliminary test data, women will be asked to listen to relaxation music every day for four weeks for 30 minutes before bedtime in a comfortable environment at home. At the end of the fourth week, the final test data will be obtained.
To the Control Group; no intervention will be made to women after the preliminary test data.At the end of the fourth week, the final test data will be obtained.
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Therapeutic Touch Group
In order to examine the effects of therapeutic touch on menopausal symptoms, sleep and quality of life, women will be given therapeutic touch for 15 minutes, once a week for four weeks.Therapeutic touchis a form of descriptive treatment that lasts approximately 15-20 minutes, in which hands are used on or near the body to correct abnormalities in the person's energy field and to achieve healing, and the energy in the universe is transferred from the practitioner's hands to the applied individual.
Therapeutic Touch
Each of the women will be informed about the purpose and content of the study at the first meeting, and informed consent will be obtained from the women who meet the conditions for participation and agree to participate. The pre-test data in the research will be obtained with the Participant Identification Form, PSQI,MRS and MENQOL. After pre-test data collection, women will be given an appointment for therapeutic administration.The therapeutic touch group will be applied to the therapeutic touch group once a week for four weeks in a suitable room in the Faculty of Nursing and on the specified day and time by the researcher.At the end of the fourth week, post-test data will be obtained by filling in PSQI, MRS and MENQOL again.
Music Listening Group
The women were asked to listen to the relaxation music included in the relaxation exercises CD prepared by the Turkish Psychological Association every day for four weeks in a comfortable environment at home for 30 minutes before bedtime.
Music Listening Group
Each of the women was informed about the purpose and content of the study at the first meeting, and informed consent was obtained from the women who met the conditions for participation and accepted to participate.The pre-test data in the research will be obtained with the Participant Identification Form, PSQI, MRS and MENQOL. Music stream, music will be uploaded to mobile phones. He will be asked to listen to music (relaxation music in the relaxation exercises CD prepared by the Turkish Psychological Association) for 30 minutes before going to sleep every day for four weeks. At the end of the fourth week, post-test data will be obtained by filling in PSQI, MRS and MENQOL again
Control Group
No action will be taken on the control group for four weeks.
Control Group
Each of the women will be informed about the purpose and content of the study at the first meeting, and informed consent will be obtained from the women who meet the conditions for participation and agree to participate.The pre-test data in the research will be obtained with the Participant Identification Form, PSQI, MRS and MENQOL. No action will be taken on the control group for four weeks. At the end of the fourth week, post-test data will be obtained by filling in PSQI, MRS and MENQOL again.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Therapeutic Touch
Each of the women will be informed about the purpose and content of the study at the first meeting, and informed consent will be obtained from the women who meet the conditions for participation and agree to participate. The pre-test data in the research will be obtained with the Participant Identification Form, PSQI,MRS and MENQOL. After pre-test data collection, women will be given an appointment for therapeutic administration.The therapeutic touch group will be applied to the therapeutic touch group once a week for four weeks in a suitable room in the Faculty of Nursing and on the specified day and time by the researcher.At the end of the fourth week, post-test data will be obtained by filling in PSQI, MRS and MENQOL again.
Music Listening Group
Each of the women was informed about the purpose and content of the study at the first meeting, and informed consent was obtained from the women who met the conditions for participation and accepted to participate.The pre-test data in the research will be obtained with the Participant Identification Form, PSQI, MRS and MENQOL. Music stream, music will be uploaded to mobile phones. He will be asked to listen to music (relaxation music in the relaxation exercises CD prepared by the Turkish Psychological Association) for 30 minutes before going to sleep every day for four weeks. At the end of the fourth week, post-test data will be obtained by filling in PSQI, MRS and MENQOL again
Control Group
Each of the women will be informed about the purpose and content of the study at the first meeting, and informed consent will be obtained from the women who meet the conditions for participation and agree to participate.The pre-test data in the research will be obtained with the Participant Identification Form, PSQI, MRS and MENQOL. No action will be taken on the control group for four weeks. At the end of the fourth week, post-test data will be obtained by filling in PSQI, MRS and MENQOL again.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Not taking Hormone Replacement Therapy,
* No psychiatric history,
* Women who do not use any other CAM methods will be included in the study.
Exclusion Criteria
* Having auditory problems that prevent listening to music,
* Using any other TAT method,
* Women who use drugs that affect sleep (using antidepressant, antihistamine, benzodiazepan, hypnotic and narcotic drugs) will be excluded from the study.
45 Years
59 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Inonu University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Fatma Keskin
Research Assistant
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
FATMA KESKİN
Role: PRINCIPAL_INVESTIGATOR
Inonu University
YURDAGÜL YAĞMUR, Professor
Role: STUDY_DIRECTOR
Inonu University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Inonu University
Malatya, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Abedian Z, Eskandari L, Abdi H, Ebrahimzadeh S. The Effect of Acupressure on Sleep Quality in Menopausal Women: A Randomized Control Trial. Iran J Med Sci. 2015 Jul;40(4):328-34.
Marlatt KL, Beyl RA, Redman LM. A qualitative assessment of health behaviors and experiences during menopause: A cross-sectional, observational study. Maturitas. 2018 Oct;116:36-42. doi: 10.1016/j.maturitas.2018.07.014. Epub 2018 Jul 21.
Kamalifard M, Farshbaf-Khalili A, Namadian M, Ranjbar Y, Herizchi S. Comparison of the effect of lavender and bitter orange on sleep quality in postmenopausal women: A triple-blind, randomized, controlled clinical trial. Women Health. 2018 Sep;58(8):851-865. doi: 10.1080/03630242.2017.1353575. Epub 2017 Aug 25.
Adimi Naghan P, Hassani S, Sadr M, Malekmohammad M, Khoundabi B, Setareh J, Seyedmehdi SM, Seifi S. Sleep Disorders and Mental Health in Menopausal Women in Tehran. Tanaffos. 2020 Jan;19(1):31-37.
Xu Q, Lang CP. Examining the relationship between subjective sleep disturbance and menopause: a systematic review and meta-analysis. Menopause. 2014 Dec;21(12):1301-18. doi: 10.1097/GME.0000000000000240.
Moudi A, Dashtgard A, Salehiniya H, Sadat Katebi M, Reza Razmara M, Reza Jani M. The relationship between health-promoting lifestyle and sleep quality in postmenopausal women. Biomedicine (Taipei). 2018 Jun;8(2):11. doi: 10.1051/bmdcn/2018080211. Epub 2018 May 28.
Cintron D, Lipford M, Larrea-Mantilla L, Spencer-Bonilla G, Lloyd R, Gionfriddo MR, Gunjal S, Farrell AM, Miller VM, Murad MH. Efficacy of menopausal hormone therapy on sleep quality: systematic review and meta-analysis. Endocrine. 2017 Mar;55(3):702-711. doi: 10.1007/s12020-016-1072-9. Epub 2016 Aug 11.
Cao Y, Yin X, Soto-Aguilar F, Liu Y, Yin P, Wu J, Zhu B, Li W, Lao L, Xu S. Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial. Trials. 2016 Nov 16;17(1):546. doi: 10.1186/s13063-016-1670-0.
Lima AM, Rocha JSB, Reis VMCP, Silveira MF, Caldeira AP, Freitas RF, Popoff DAV. [Loss of quality of sleep and associated factors among menopausal women]. Cien Saude Colet. 2019 Jul 22;24(7):2667-2678. doi: 10.1590/1413-81232018247.19522017. Portuguese.
Attarian H, Hachul H, Guttuso T, Phillips B. Treatment of chronic insomnia disorder in menopause: evaluation of literature. Menopause. 2015 Jun;22(6):674-84. doi: 10.1097/GME.0000000000000348.
Crivello, A., Barsocchi, P., Girolami, M., & Palumbo, F. (2019). The meaning of sleep quality: a survey of available technologies. IEEE access, 7, 167374-167390.
Troynikov O, Watson CG, Nawaz N. Sleep environments and sleep physiology: A review. J Therm Biol. 2018 Dec;78:192-203. doi: 10.1016/j.jtherbio.2018.09.012. Epub 2018 Oct 5.
Hachul, H., & Polesel, D. N. (2017). Insomnia pharmacotherapy: a review of current treatment options for insomnia in menopause. Current sleep medicine reports, 3(4), 299-305.
Afonso RF, Hachul H, Kozasa EH, Oliveira Dde S, Goto V, Rodrigues D, Tufik S, Leite JR. Yoga decreases insomnia in postmenopausal women: a randomized clinical trial. Menopause. 2012 Feb;19(2):186-93. doi: 10.1097/gme.0b013e318228225f.
Johnson A, Roberts L, Elkins G. Complementary and Alternative Medicine for Menopause. J Evid Based Integr Med. 2019 Jan-Dec;24:2515690X19829380. doi: 10.1177/2515690X19829380.
HÖzcan, H., Çakmak, S., & Salman, E. (2020). Complementary and Alternative Medicine Methods Used for Sleep Disturbance in Menopause. Journal of Turkish Sleep Medicine, 3, 207-213.
Vardar, O., Özkan, S., & Sercekus, P. (2020). Postmenopozal kadınlarda uygulanan egzersiz programının uyku kalitesine etkisi. Cukurova Medical Journal, 45(3), 1108-1114.
j. V. Dall, "Promoting sleep with therapeutic touch," Addict. Nurs. Netw., vol. 5, no. 1, pp. 23-24, 1993.
Tabatabaee A, Tafreshi MZ, Rassouli M, Aledavood SA, AlaviMajd H, Farahmand SK. Effect of Therapeutic Touch in Patients with Cancer: a Literature Review. Med Arch. 2016 Apr;70(2):142-7. doi: 10.5455/medarh.2016.70.142-147. Epub 2016 Apr 1.
Cordi MJ, Ackermann S, Rasch B. Effects of Relaxing Music on Healthy Sleep. Sci Rep. 2019 Jun 24;9(1):9079. doi: 10.1038/s41598-019-45608-y.
Liu YH, Lee CS, Yu CH, Chen CH. Effects of music listening on stress, anxiety, and sleep quality for sleep-disturbed pregnant women. Women Health. 2016;56(3):296-311. doi: 10.1080/03630242.2015.1088116. Epub 2015 Sep 11.
Dickson GT, Schubert E. How does music aid sleep? literature review. Sleep Med. 2019 Nov;63:142-150. doi: 10.1016/j.sleep.2019.05.016. Epub 2019 Jun 8.
Chen CT, Tung HH, Fang CJ, Wang JL, Ko NY, Chang YJ, Chen YC. Effect of music therapy on improving sleep quality in older adults: A systematic review and meta-analysis. J Am Geriatr Soc. 2021 Jul;69(7):1925-1932. doi: 10.1111/jgs.17149. Epub 2021 Apr 20.
J. Cohen, Statistical Power Analysis for the Behavioral Sciences., 2nd ed. 1988.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
M. Ağargün, H. Kara, and Ö. Anlar, "Pitsburg Uyku Kalitesi İndeksinin Geçerliği ve Güvenirliği.," Türk Psikiyatr. Derg., vol. 7, no. 2, 1996.
Ö. C. Gürkan, "Menopoz semptomları değerlendirme ölçeğinin Türkçe formunun güvenirlik ve geçerliliği.," Hemşirelik Forumu Derg., vol. 3, pp. 30-35, 2005.
Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8.
N. H. ŞAHİN, N. H., Kharbouch, S. B., & Şahin, "Menopozal dönemlerdeki yaşam kalitesinin belirlenmesi.," Florence Nightingale Hemşirelik Dergisi, vol. 15, no. 59, pp. 82-90, 2007.
Meehan TC. Therapeutic touch as a nursing intervention. J Adv Nurs. 1998 Jul;28(1):117-25. doi: 10.1046/j.1365-2648.1998.00771.x.
J. Macrae, Therapeutic Touch. izmir: Ege Meta Yayınları, 2000.
Keskin Tore F, Yagmur Y. The effects of therapeutic touch and music on sleep quality, menopausal symptoms, and quality of life in menopausal women. Menopause. 2023 Dec 1;30(12):1221-1229. doi: 10.1097/GME.0000000000002269. Epub 2023 Oct 24.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
menopause
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.