AromatherapyNCT06119282
The Effect of Aromatherapy in Women With Primiparous Cesarean Section
A study testing inhaler and massage in people with Aromatherapy and Cesarean Section Complications, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aromatherapy, Cesarean Section Complications, Primiparity
- What is being tested?
- inhaler and massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.),
Show all 9Show fewer
- No emergency cesarean section complication (EDT, pregnant with bleeding, etc.),
- Not allergic to aromatherapy oils to be applied,
- Presence of sense of smell.
Who cannot join
- Wanting to stop working
- Complications during/after cesarean section,
- Being multiparous
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Research Hospital
Istanbul, Fatih, 34020
About this study
Official title: The Effect of Aromatherapy on Acute Pain Anxiety and Comfort Levels in Women With Primiparous Cesarean Section Randomized Controlled Study
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.
Read the detailed description
- Essential Oils and Preparation Steps: Obstetrics and Gynecology Specialist, who has a Phytotherapy Certificate approved by the Ministry of Health, in the selection of essential oils, the creation and dilution of the essential mixture. Instructor Consultancy was received from its member Ayşe Şeyma Küçükakça.
- Preparation of Essential Mixture: It should be preferred to use essential oils as a mixture rather than using them alone. The reason for this is to benefit from the synergy created by essential oils. While a mixture of 5 essential oils is preferred in general use, a maximum of 3 essential oils are used after delivery. Note system is used to create synergy between essential oils. The mixture is created by choosing 1 oil from the top note, middle note and bottom note oils. In the essential blend, the first to be smelled is the top note, the middle note is followed by the top note, and the last is the bottom note. The effect of the oils in the mixture is revealed by the heat, and the effect of the oils in the bottom note is revealed. While creating the essential mixture, essential oils with the same effect are preferred to support the desired effect, and top notes can be used to lighten the aroma of these two oils. Mandarin (Citrus Nobilis): Top note is citrus essential oil. It has antimicrobial, antiseptic, antispasmodic, anti-inflammatory, diuretic, sleep quality-enhancing, antidepressant, anxiety and stress relieving properties. There is no known side effects. However, exposure to sunlight should be avoided until 12 hours after the application. It can be used with 3%-50% dilution. It creates synergy with lavender and vetiver. Lavender (Lavandula Angustifolia): Middle note is a floral essential oil. Its effects are analgesic, supportive of skin health, antibacterial, anti-inflammatory, antiseptic, relaxant, antipyretic, improving sleep quality, balancing blood pressure, antidepressant, reducing stress, fear and anxiety, and helps panic attacks. There is no known side effects. It can be used in 5%-pure form. Vetiver creates synergy with Mandarin. Vetiver (Vetiveria zizanoides): Vetiver is woody essential oil from the base notes. Its effects are analgesic, antibacterial, antimicrobial, helping cell regeneration, antispasmodic, improving sleep quality, reducing anxiety and stress, increasing focus and concentration, antidepressant, helping anger control and helping to get rid of negative emotions such as fear. There is no known side effects. It can be used with 5%-50% dilution. It creates synergy with lavender and tangerine. Grape Seed Oil: It is a carrier oil suitable for all skin types. It is antiallergic. It has skin moisturizing properties. It is odorless, tasteless and easily absorbed. It has antioxidant properties. It contains high amount of vitamin E. It helps wound healing and cell regeneration. It has anti-inflammatory and calming properties.
- Dilution of Essential Oils: Essential oils should be diluted with carrier oils. The dilution rate is recommen*ded as 1% for children and 2% for adults. The base oil to be used in dilution is 1% dilution rate as 3 drops of essential oil per 5 ml of base oil. The essential oils to be used in the research will be applied by diluting 1% in order to be easy to tolerate and to reduce the possibility of reaction. 3 drops of tangerine, 2 drops of lavender and 1 drop of vetiver will be added to 10 ml of grape seed oil. As tangerine is the top note, its volatility is high. Therefore, 3 drops will be used. Lavender is the middle note essential oil and again volatile. 2 drops will be added to the essential mixture. Vetiver is a base oil. It is more permanent. Therefore, 1 drop will be used.
- Inhaler Administration Guide: 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.
- Massage Application Guide: 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. Before the Application; A room with an average temperature of 25 °C and far from noise is arranged for the massage. An examination table, chair or patient bed of appropriate width (60-65 cm) and height (70-80 cm) is used for the procedure. After the postpartum woman is brought to a comfortable position, she is given a side lying/inverted sitting position on the chair and the abdominal region is supported. The patient's clothing is removed from his shoulders to the sacral region, exposing his back. If the patient's body is damp and sweaty, it is wiped with a paper towel. Hands are washed and warmed by rubbing against each other. According to the patient's back area, 2-4 ml of essential oil, which has been approximately warmed by the bain-marie method, is taken into the palm of the hand and applied to the patient's back and massaged. Massage begins in the direction of the heart and by following the direction of the muscle fibers.
- Control Group Follow-up Guide:
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.
- Being tested
- inhaler, Control Group, massage
- Keywords
- Aromatherapy, Cesarean Section, Primiparity, Postpartum Period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhalerOther
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.
Control GroupOther
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.
massageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jun 2022
- Primary completion9 Jan 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for AromatherapyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülnihal ARTUĞ CANSIZLAR, Istanbul University - Cerrahpasa
- Investigators
- Gülnihal ARTUĞ CANSIZLAR, 1, Principal investigator, Istanbul University Cerrahpasa Florence Nightingale Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119282
- Sponsor's protocol ID
- The Effect of Aromatherapy
- Status last verified
- Sep 2024
- First submitted
- 22 Dec 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32049695Hajibagheri 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.
PubMed 25129884Ueki 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.
PubMed 25453522Johnson 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.
PubMed 28237089Cankaya 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.
PubMed 32078754Keshavarz 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.
PubMed 26023343Einion A. Aromatherapy in midwifery practice. Pract Midwife. 2016 May;19(5):12, 14-5.
PubMed 27295753Cutshall 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.
PubMed 20347840Lee 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.
PubMed 26125572Ovayolu 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.
Özdemir H, Öztunç G. Hemşirelik uygulamalarında aromaterapi. Türkiye Klinikleri Hemşirelik Bilimleri Dergisi. 2013;5(2):98-104.
Bilgiç Ş. Hemşirelikte Holistik Bir Uygulama; Aromaterapi. Namık Kemal Tıp Dergisi, 2017; 5(3): 134-141.
Kavurmacı M, Tan M. Üremik kaşıntı ve aromaterapi uygulaması. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi. 2014;3(1):674-82.
Zor M, Küçükkelepçe Şimşek D, Gölbaşı Z. Türkiye'de aromaterapinin etkisine yönelik yapılan hemşirelik tezlerinin incelenmesi. Türk J. Clin. Lab. 2021; 1: 77-94.
Şimşek Elmalı H, Alpar Ecevit Ş. Sezaryen Sonrası Ağrı ve Hemşirelik Bakımı. IGUSABDER, 2020: 11; 267-278.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy on Acute Pain Anxiety and Comfort Levels in Women With Primiparous Cesarean Section Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06119282
- Acronym / sponsor ID
- The Effect of Aromatherapy
- Keywords
- Aromatherapy, Cesarean Section, Primiparity, Postpartum Period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Essential Oils and Preparation Steps: Obstetrics and Gynecology Specialist, who has a Phytotherapy Certificate approved by the Ministry of Health, in the selection of essential oils, the creation and dilution of the essential mixture. Instructor Consultancy was received from its member Ayşe Şeyma Küçükakça.
- Preparation of Essential Mixture: It should be preferred to use essential oils as a mixture rather than using them alone. The reason for this is to benefit from the synergy created by essential oils. While a mixture of 5 essential oils is preferred in general use, a maximum of 3 essential oils are used after delivery. Note system is used to create synergy between essential oils. The mixture is created by choosing 1 oil from the top note, middle note and bottom note oils. In the essential blend, the first to be smelled is the top note, the middle note is followed by the top note, and the last is the bottom note. The effect of the oils in the mixture is revealed by the heat, and the effect of the oils in the bottom note is revealed. While creating the essential mixture, essential oils with the same effect are preferred to support the desired effect, and top notes can be used to lighten the aroma of these two oils. Mandarin (Citrus Nobilis): Top note is citrus essential oil. It has antimicrobial, antiseptic, antispasmodic, anti-inflammatory, diuretic, sleep quality-enhancing, antidepressant, anxiety and stress relieving properties. There is no known side effects. However, exposure to sunlight should be avoided until 12 hours after the application. It can be used with 3%-50% dilution. It creates synergy with lavender and vetiver. Lavender (Lavandula Angustifolia): Middle note is a floral essential oil. Its effects are analgesic, supportive of skin health, antibacterial, anti-inflammatory, antiseptic, relaxant, antipyretic, improving sleep quality, balancing blood pressure, antidepressant, reducing stress, fear and anxiety, and helps panic attacks. There is no known side effects. It can be used in 5%-pure form. Vetiver creates synergy with Mandarin. Vetiver (Vetiveria zizanoides): Vetiver is woody essential oil from the base notes. Its effects are analgesic, antibacterial, antimicrobial, helping cell regeneration, antispasmodic, improving sleep quality, reducing anxiety and stress, increasing focus and concentration, antidepressant, helping anger control and helping to get rid of negative emotions such as fear. There is no known side effects. It can be used with 5%-50% dilution. It creates synergy with lavender and tangerine. Grape Seed Oil: It is a carrier oil suitable for all skin types. It is antiallergic. It has skin moisturizing properties. It is odorless, tasteless and easily absorbed. It has antioxidant properties. It contains high amount of vitamin E. It helps wound healing and cell regeneration. It has anti-inflammatory and calming properties.
- Dilution of Essential Oils: Essential oils should be diluted with carrier oils. The dilution rate is recommen*ded as 1% for children and 2% for adults. The base oil to be used in dilution is 1% dilution rate as 3 drops of essential oil per 5 ml of base oil. The essential oils to be used in the research will be applied by diluting 1% in order to be easy to tolerate and to reduce the possibility of reaction. 3 drops of tangerine, 2 drops of lavender and 1 drop of vetiver will be added to 10 ml of grape seed oil. As tangerine is the top note, its volatility is high. Therefore, 3 drops will be used. Lavender is the middle note essential oil and again volatile. 2 drops will be added to the essential mixture. Vetiver is a base oil. It is more permanent. Therefore, 1 drop will be used.
- Inhaler Administration Guide: 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.
- Massage Application Guide: 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. Before the Application; A room with an average temperature of 25 °C and far from noise is arranged for the massage. An examination table, chair or patient bed of appropriate width (60-65 cm) and height (70-80 cm) is used for the procedure. After the postpartum woman is brought to a comfortable position, she is given a side lying/inverted sitting position on the chair and the abdominal region is supported. The patient's clothing is removed from his shoulders to the sacral region, exposing his back. If the patient's body is damp and sweaty, it is wiped with a paper towel. Hands are washed and warmed by rubbing against each other. According to the patient's back area, 2-4 ml of essential oil, which has been approximately warmed by the bain-marie method, is taken into the palm of the hand and applied to the patient's back and massaged. Massage begins in the direction of the heart and by following the direction of the muscle fibers.
- Control Group Follow-up Guide:
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Test İnhaler | Experimental | Other: inhalerAfter 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 Massage | Experimental | Other: massageWhen 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. |
| Control Group | Active comparator | Other: Control GroupPregnant 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (3 listed)
- Wanting to stop working
- Complications during/after cesarean section,
- Being multiparous
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhalerExperimental: 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 | Test İnhaler |
| Control GroupControl 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. | Other | Control Group |
| massageExperimental: 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. | Other | Test Massage |
Primary outcome
Visual analog scale (VAS)
Time frame: 2 days
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
State-Trait Anxiety Inventory
Time frame: 2 days
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
Postpartum Comfort Questionnaire (PPCQ)
Time frame: 2 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 32049695Aydin 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.
- Background: PubMed 25129884Hajibagheri 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.
- Background: PubMed 25453522Ueki 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.
- Background: PubMed 28237089Johnson 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.
- Background: PubMed 32078754Cankaya 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.
- Background: PubMed 26023343Keshavarz 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.
- Background: PubMed 27295753Einion A. Aromatherapy in midwifery practice. Pract Midwife. 2016 May;19(5):12, 14-5.
- Background: PubMed 20347840Cutshall 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.
- Background: PubMed 26125572Lee 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.
- BackgroundOvayolu 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.
- BackgroundÖzdemir H, Öztunç G. Hemşirelik uygulamalarında aromaterapi. Türkiye Klinikleri Hemşirelik Bilimleri Dergisi. 2013;5(2):98-104.
- BackgroundBilgiç Ş. Hemşirelikte Holistik Bir Uygulama; Aromaterapi. Namık Kemal Tıp Dergisi, 2017; 5(3): 134-141.
- Is it safe to use essential oil "neat" (undiluted) on the skin?Link provided by the sponsor.
- Knowing how to calculate dilutions is crucial to the safe practice of aromatherapy.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülnihal ARTUĞ CANSIZLAR, 1 principal investigator
Istanbul University Cerrahpasa Florence Nightingale Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inhaler and massage in people with Aromatherapy and Cesarean Section Complications, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: 2 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06119282, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.