Cesarean Section Complications Clinical Trial
Official title:
The Effect of Aromatherapy on Acute Pain Anxiety and Comfort Levels in Women With Primiparous Cesarean Section Randomized Controlled Study
Verified date | March 2024 |
Source | Istanbul University - Cerrahpasa (IUC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was organized as a randomized controlled trial. The sample was calculated as 120 (Control: 60, Experiment 1:30 Experiment 2:30). Primiparous cesarean section women will be evaluated for pain, postpartum comfort and anxiety levels by using lavender oil, tangerine oil and vetiver oil. The first group will be given inhaler application, the second group will be massage and aromatherapy application. The third group will be the control group.
Status | Enrolling by invitation |
Enrollment | 120 |
Est. completion date | May 28, 2024 |
Est. primary completion date | March 20, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria - Being able to speak, read and write Turkish, - Agree to work with selected essential oils, - Over 18 years of age and volunteering to participate in the study, - Being nulliparous - Not having a previous surgical operation history, - Not to be a risky pregnancy (HT, Gestational diabetes, asthma, etc.), - No emergency cesarean section complication (EDT, pregnant with bleeding, etc.), - Not allergic to aromatherapy oils to be applied, - Presence of sense of smell. Exclusion Criteria: - Wanting to stop working - Complications during/after cesarean section, - Being multiparous |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Training and Research Hospital | Istanbul | Fatih |
Lead Sponsor | Collaborator |
---|---|
Istanbul University - Cerrahpasa (IUC) |
Turkey,
Aydin Yildirim T, Kitis Y. The Effect of Aromatherapy Application on Cognitive Functions and Daytime Sleepiness in Older Adults Living in a Nursing Home. Holist Nurs Pract. 2020 Mar/Apr;34(2):83-90. doi: 10.1097/HNP.0000000000000371. — View Citation
Ayik C. Ameliyat Öncesi Dönemde Aromaterapi Masajinin Anksiyete Ve Uyku Kalitesine Etkisinin Incelenmesi (Yüksek Lisans Tezi). Dokuz Eylül Üniversitesi Saglik Bilimleri Enstitüsü, 2016.
Bilgiç S. Hemsirelikte Holistik Bir Uygulama; Aromaterapi. Namik Kemal Tip Dergisi, 2017; 5(3): 134-141.
Boz I, Selvi N. Dogum Sonu Dönemde Iyi Bakim Uygulamalari: Kanitlarla Tamamlayici Terapiler. Anadolu Hemsirelik ve Saglik Bilimleri Dergisi, 2016;19: 25-32.
Cankaya S, Ratwisch G. The Effect of Reflexology on Lactation and Postpartum Comfort in Caesarean-Delivery Primiparous Mothers: A Randomized Controlled Study. Int J Nurs Pract. 2020 Jun;26(3):e12824. doi: 10.1111/ijn.12824. Epub 2020 Feb 20. — View Citation
Çapik A, Özkan H, Ejder Apay S. Logusalarin dogum sonu konfor düzeyleri ve etkileyen faktörlerin belirlenmesi. Dokuz Eylül Üniversitesi Hemsirelik Yüksekokulu Elektronik Dergisi. 2014;7(3):186-192.
Cutshall SM, Wentworth LJ, Engen D, Sundt TM, Kelly RF, Bauer BA. Effect of massage therapy on pain, anxiety, and tension in cardiac surgical patients: a pilot study. Complement Ther Clin Pract. 2010 May;16(2):92-5. doi: 10.1016/j.ctcp.2009.10.006. Epub 2009 Nov 14. — View Citation
Einion A. Aromatherapy in midwifery practice. Pract Midwife. 2016 May;19(5):12, 14-5. — View Citation
Hajibagheri A, Babaii A, Adib-Hajbaghery M. Effect of Rosa damascene aromatherapy on sleep quality in cardiac patients: a randomized controlled trial. Complement Ther Clin Pract. 2014 Aug;20(3):159-63. doi: 10.1016/j.ctcp.2014.05.001. Epub 2014 May 14. — View Citation
Johnson K, West T, Diana S, Todd J, Haynes B, Bernhardt J, Johnson R. Use of aromatherapy to promote a therapeutic nurse environment. Intensive Crit Care Nurs. 2017 Jun;40:18-25. doi: 10.1016/j.iccn.2017.01.006. Epub 2017 Feb 23. — View Citation
Karaman Özlü Z, Soydan S, Çapik A, ve ark. Sezaryen ameliyati olan lohusalarda progresif gevseme egzersizlerini agri kontrolü üzerine etkisi. Anadolu Hemsirelik ve Saglik Bilimleri Dergisi.2016;19(1):58-64.
Kaufmann C. Aromatic Alchemy For Well-Being. New York; The Country Man Press, 2018.
Kavurmaci M, Tan M. Üremik kasinti ve aromaterapi uygulamasi. Gümüshane Üniversitesi Saglik Bilimleri Dergisi. 2014;3(1):674-82.
Keshavarz Afshar M, Behboodi Moghadam Z, Taghizadeh Z, Bekhradi R, Montazeri A, Mokhtari P. Lavender fragrance essential oil and the quality of sleep in postpartum women. Iran Red Crescent Med J. 2015 Apr 25;17(4):e25880. doi: 10.5812/ircmj.17(4)2015.25880. eCollection 2015 Apr. — View Citation
Lee HJ, Ko YL. Back massage intervention for relieving lower back pain in puerperal women: A randomized control trial study. Int J Nurs Pract. 2015 May;21 Suppl 2:32-7. doi: 10.1111/ijn.12299. — View Citation
Ovayolu Ö. Kemoterapi alan meme kanserli kadinlara uygulanan aromaterapinin semptomlara ve yasam kalitesine etkisi, Erciyes Üniversitesi Saglik Bilimleri Enstitüsü Hemsirelik Anabilim Dali. Doktora Tezi. 2011; Kayseri.3.
Özdemir H, Öztunç G. Hemsirelik uygulamalarinda aromaterapi. Türkiye Klinikleri Hemsirelik Bilimleri Dergisi. 2013;5(2):98-104.
Rathfisch G. Kadin Sagliginda Klinik Aromaterapi. Adana; Çukurova Nobel Tip, 2019.
Sahin N, Aydin D, Akay B. Hemsirelik Ögrencilerinin Bütüncül Tamamlayici Ve Alternatif Tibba Karsi Tutumlarinin Degerlendirilmesi. Balikesir Saglik Bilimleri Dergisi, 2019; 8(1):21-26.
Simsek Elmali H, Alpar Ecevit S. Sezaryen Sonrasi Agri ve Hemsirelik Bakimi. IGUSABDER, 2020: 11; 267-278.
Ueki S, Niinomi K, Takashima Y, Kimura R, Komai K, Murakami K, Fujiwara C. Effectiveness of aromatherapy in decreasing maternal anxiety for a sick child undergoing infusion in a paediatric clinic. Complement Ther Med. 2014 Dec;22(6):1019-26. doi: 10.1016/j.ctim.2014.09.004. Epub 2014 Sep 30. — View Citation
Zor M, Küçükkelepçe Simsek D, Gölbasi Z. Türkiye'de aromaterapinin etkisine yönelik yapilan hemsirelik tezlerinin incelenmesi. Türk J. Clin. Lab. 2021; 1: 77-94.
* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual analog scale (VAS) | Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end.
The patient marks on the line the point that they feel represents their perception of their current state. Min: 0, Max: 10 |
2 days | |
Primary | State-Trait Anxiety Inventory | Spielberger, like Raymond Cattell and others before him, made the conceptual distinction between chronic or trait anxiety (a general propensity to be anxious) and temporary or state anxiety (a temporary state varying in intensity). min.: 20- max.: 80 | 2 days | |
Primary | Postpartum Comfort Questionnaire (PPCQ) | It is decided that the developed PPCQ is a clinically reliable instrument to measure the postpartum comfort of the mothers who give birth. min: 34, Max: 170 | 2 days |
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