Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06119282
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2022-12-22
Brief Title:
The Effect of Aromatherapy in Women With Primiparous Cesarean Section
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
The Effect of Aromatherapy on Acute Pain Anxiety and Comfort Levels in Women With Primiparous Cesarean Section Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was organized as a randomized controlled trial The sample was calculated as 120 Control 60 Experiment 130 Experiment 230 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:
1 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
2 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
3 Dilution of Essential Oils
Essential oils should be diluted with carrier oils The dilution rate is recommended 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
4 Inhaler Administration Guide
After the cesarean section at the 8th hour postpartum the VASGCA 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 41 women are allowed to sniff Before the application the 30th and 60th minutes VASGOC vital parameters are evaluated
5 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 11 2 times on the postoperative 1st and 2nd days when the woman feels ready 30 and 60 minutes before application then VASGCS 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 lyinginverted sitting position on the chair and the abdominal region is supported
The patients clothing is removed from his shoulders to the sacral region exposing his back If the patients 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 patients 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 patients back and massaged
Massage begins in the direction of the heart and by following the direction of the muscle fibers
6 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
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
2 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
3 Dilution of Essential Oils
Essential oils should be diluted with carrier oils The dilution rate is recommended 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
4 Inhaler Administration Guide
After the cesarean section at the 8th hour postpartum the VASGCA 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 41 women are allowed to sniff Before the application the 30th and 60th minutes VASGOC vital parameters are evaluated
5 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 11 2 times on the postoperative 1st and 2nd days when the woman feels ready 30 and 60 minutes before application then VASGCS 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 lyinginverted sitting position on the chair and the abdominal region is supported
The patients clothing is removed from his shoulders to the sacral region exposing his back If the patients 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 patients 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 patients back and massaged
Massage begins in the direction of the heart and by following the direction of the muscle fibers
6 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None