The Effect of Aromatherapy in Women With Primiparous Cesarean Section

NCT06119282 | Completed

• 1 other identifier: The Effect of Aromatherapy
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aromatherapy; Cesarean Section Complications; Primiparity; Postpartum Period

Keywords

Aromatherapy; Cesarean Section; Primiparity; Postpartum Period

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Postpartum Comfort Questionnaire (PPCQ)

  İt 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

Study Arms (3)

Test İnhaler

EXPERIMENTAL

After the cesarean section, at the 8th hour postpartum, the VAS/GCA is evaluated, 4 drops of carrier oil are dropped on the upper and lower parts of the wick of the aroma stick, and then 15-20 drops of the prepared essential mixture are dropped and the woman is explained about its use. By the 8th hour of the postop, 4\*1 women are allowed to sniff. Before the application, the 30th and 60th minutes VAS/GOC, vital parameters are evaluated.

Other: inhaler

Test Massage

EXPERIMENTAL

When the studies conducted with the massage method are examined, back massage is applied for 10-30 minutes. Considering the working conditions of the institution, it is thought that a 10-minute massage may be sufficient for the application. The massage application is started at the postpartum 8th hour and applied for 10 minutes on the postoperative 0th day 1\*1, 2 times on the postoperative 1st and 2nd days when the woman feels ready. 30 and 60 minutes before application. then VAS/GCS, vital parameters are monitored.

Other: massage

Control Group

ACTIVE COMPARATOR

Pregnant women included in the control group will be left to clinical care, and pain and vital parameters will be monitored starting from the 8th postoperative hour. The scales applied to the experimental groups will be applied on the 2nd postoperative day. Women in the control group who completed the study will be informed about the postpartum use of aromatherapy. Women who want aromatherapy application will be directed to GETAT center.

Other: Control Group

Interventions

inhaler OTHER

Experimental: After the cesarean section, at the 8th hour postpartum, the VAS/GCA is evaluated, 4 drops of carrier oil are dropped on the upper and lower parts of the wick of the aroma stick, and then 15-20 drops of the prepared essential mixture are dropped and the woman is explained about its use. By the 8th hour of the postop, 4\*1 women are allowed to sniff. Before the application, the 30th and 60th minutes VAS/GOC, vital parameters are evaluated.

Test İnhaler

Control Group OTHER

Control Group Pregnant women included in the control group will be left to clinical care, and pain and vital parameters will be monitored starting from the 8th postoperative hour. The scales applied to the experimental groups will be applied on the 2nd postoperative day. Women in the control group who completed the study will be informed about the postpartum use of aromatherapy. Women who want aromatherapy application will be directed to GETAT center.

Control Group

massage OTHER

Experimental: Test Massage When the studies conducted with the massage method are examined, back massage is applied for 10-30 minutes. Considering the working conditions of the institution, it is thought that a 10-minute massage may be sufficient for the application. The massage application is started at the postpartum 8th hour and applied for 10 minutes on the postoperative 0th day 1\*1, 2 times on the postoperative 1st and 2nd days when the woman feels ready. 30 and 60 minutes before application. then VAS/GCS, vital parameters are monitored.

Test Massage

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Wanting to stop working
• Complications during/after cesarean section,
• Being multiparous

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, Fatih, 34020, Turkey (Türkiye)

Location

Related Publications (22)

• 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.

  PMID: 32049695 BACKGROUND

• 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.

  PMID: 25129884 BACKGROUND

• 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.

  PMID: 25453522 BACKGROUND

• 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.

  PMID: 28237089 BACKGROUND

• 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.

  PMID: 32078754 BACKGROUND

• 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.

  PMID: 26023343 BACKGROUND

• Einion A. Aromatherapy in midwifery practice. Pract Midwife. 2016 May;19(5):12, 14-5.

  PMID: 27295753 BACKGROUND

• 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.

  PMID: 20347840 BACKGROUND

• 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.

  PMID: 26125572 BACKGROUND

• Ovayolu Ö. Kemoterapi alan meme kanserli kadınlara uygulanan aromaterapinin semptomlara ve yaşam kalitesine etkisi, Erciyes Üniversitesi Sağlık Bilimleri Enstitüsü Hemşirelik Anabilim Dalı. Doktora Tezi. 2011; Kayseri.3.

  BACKGROUND

• Özdemir H, Öztunç G. Hemşirelik uygulamalarında aromaterapi. Türkiye Klinikleri Hemşirelik Bilimleri Dergisi. 2013;5(2):98-104.

  BACKGROUND

• Bilgiç Ş. Hemşirelikte Holistik Bir Uygulama; Aromaterapi. Namık Kemal Tıp Dergisi, 2017; 5(3): 134-141.

  BACKGROUND

• Kavurmacı M, Tan M. Üremik kaşıntı ve aromaterapi uygulaması. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi. 2014;3(1):674-82.

  BACKGROUND

• Zor M, Küçükkelepçe Şimşek D, Gölbaşı Z. Türkiye'de aromaterapinin etkisine yönelik yapılan hemşirelik tezlerinin incelenmesi. Türk J. Clin. Lab. 2021; 1: 77-94.

  BACKGROUND

• Şimşek Elmalı H, Alpar Ecevit Ş. Sezaryen Sonrası Ağrı ve Hemşirelik Bakımı. IGUSABDER, 2020: 11; 267-278.

  BACKGROUND

• Çapık A, Özkan H, Ejder Apay S. Loğusaların doğum sonu konfor düzeyleri ve etkileyen faktörlerin belirlenmesi. Dokuz Eylül Üniversitesi Hemşirelik Yüksekokulu Elektronik Dergisi. 2014;7(3):186-192.

  BACKGROUND

• Karaman Özlü Z, Soydan S, Çapık A, ve ark. Sezaryen ameliyatı olan lohusalarda progresif gevşeme egzersizlerini ağrı kontrolü üzerine etkisi. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi.2016;19(1):58-64.

  BACKGROUND

• Boz İ, Selvi N. Doğum Sonu Dönemde İyi Bakım Uygulamaları: Kanıtlarla Tamamlayıcı Terapiler. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 2016;19: 25-32.

  BACKGROUND

• Şahin N, Aydın D, Akay B. Hemşirelik Öğrencilerinin Bütüncül Tamamlayıcı Ve Alternatif Tıbba Karşı Tutumlarının Değerlendirilmesi. Balıkesir Sağlık Bilimleri Dergisi, 2019; 8(1):21-26.

  BACKGROUND

• Kaufmann C. Aromatic Alchemy For Well-Being. New York; The Country Man Press, 2018.

  BACKGROUND

• Rathfısch G. Kadın Sağlığında Klinik Aromaterapi. Adana; Çukurova Nobel Tıp, 2019.

  BACKGROUND

• Ayik C. Ameliyat Öncesi Dönemde Aromaterapi Masajının Anksiyete Ve Uyku Kalitesine Etkisinin İncelenmesi (Yüksek Lisans Tezi). Dokuz Eylül Üniversitesi Sağlık Bilimleri Enstitüsü, 2016.

  BACKGROUND

Related Links

• Is it safe to use essential oil "neat" (undiluted) on the skin?
• Knowing how to calculate dilutions is crucial to the safe practice of aromatherapy.

MeSH Terms

Interventions

Nebulizers and Vaporizers; Control Groups; Massage

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gülnihal ARTUĞ CANSIZLAR, 1

  Istanbul University Cerrahpasa Florence Nightingale Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc. Gynecology and Obstetrics Nurse

Model Details: The research will be conducted as a randomized controlled intervention study to evaluate and compare the effects of massage and inhaler aromatherapy on acute pain, comfort level and anxiety in primiparous cesarean section women.

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: November 7, 2023
• Study Start: June 1, 2022
• Primary Completion: January 9, 2024
• Study Completion: September 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TU (1)