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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vyAyAmaH, वà¥à¤¯à¤¾à¤¯à¤¾à¤®à¤ƒ | (Procedure Reference: Natyashastra, Procedure details: Loosening Exercise – 10Min Adavu – 15Min Borg RPE -12-14 Scale Abhinaya - Garbhasamvada – 15Min Cooling Exercise Relaxing Exercise and Pranayama- 20Min with Borg RPE 10-12 scale Designed as per ACOG guidelines Total duration 60mins/day )) (1) Medicine Name: dhatri lauha, Reference: A.F.I.-1:284, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 12 Weeks(2) Medicine Name: jivanti churna, Reference: API part1:vol4 :32, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 12 Weeks(3) Medicine Name: gokshura , Reference: API part 1:Vol 1:26, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 12 Weeks | | 2 | Comparator Arm | Procedure | - | mantra-cikitsA, मनà¥à¤¤à¥à¤°-चिकितà¥à¤¸à¤¾ | (Procedure Reference: charaka samhita shareera sthana 8/3, Procedure details: Raga Mohana & Kalyani instrument- Flute /Violin/ vocal (Below 60 Db) along with garbha samvada (creative visualization and self-interaction of pregnant women with the foetus) total duration of 60mins per day) (1) Medicine Name: dhatri lauha, Reference: A.F.I.-1:284, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 12 Weeks(2) Medicine Name: jivanti churna, Reference: API part1:vol4 :32, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 12 Weeks(3) Medicine Name: gokshura, Reference: API part 1:Vol 1:26, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 12 Weeks | | 3 | Comparator Arm (Non Ayurveda) | | - | Standard WHO group | 1.Supplementary nutritional therapy – Oral administration. Above 10% of hemoglobin 1 tablet ferrous sulphate (Containing 60 mg of elemental iron) Daily once 2.Tablet containing 500 mg elemental calcium and 250 IU Vitamin D3 Each tablet twice daily Duration: 12weeks |
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Brief Summary
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Need for the study-
The Grabhasamskara Protocol is a well-established Ayurvedic
intervention that has been utilized for promoting maternal and foetal health
during pregnancy. This protocol, which includes a combination of dietary
recommendations, lifestyle modifications, and herbal supplements, has been
shown to have positive effects on both the physical and mental well-being of
pregnant women and their unborn children.
Dance therapy is another
intervention that has been gaining recognition for its potential benefits
during pregnancy[i]. It involves the use of
movement and dance as a form of therapy, and it has been shown to have positive
effects on both physical and mental health. Studies have shown that Dance can
help reduce stress, improve mood, and increase overall well-being in pregnant
women Indian classical dance forms have a soothing and emotional impact on the
mother, that in turn will have better maternal and foetal outcomes.
Despite the potential
benefits of both Gabhasamskara and Dance
Therapy, there is limited research on the combined effects of these
interventions during pregnancy. Therefore, the need for this study is to
investigate the potential synergistic effects of Gabhasamskara with and without classical dance therapy on maternal
and foetal health during pregnancy. By examining the combined effects of these
interventions, we can gain a better understanding of how they can be used
together to promote the health and well-being of pregnant women and their
unborn child.
Research Gap Analysis- Lack of empirical evidence
exploring the combined effects of Classical Dance Therapy with Gabhasamskara
Protocol on maternal and foetal outcomes. Previous studies have
primarily focused on either Gabhasamskara techniques or aerobic dance
therapy, leaving a notable void in understanding the potential synergistic
benefits of integrating both modalities. This trial aims to bridge this gap by
providing valuable insights into the efficacy of such integrated approaches,
thus addressing a critical gap.
RATIONALE OF THE TRIAL
PROTOCOL
The protocol is designed with combination of Physical
work- up and emotional expression. As recommended by ACOG physical exercise of
30min regularly have a good impact on labour outcomes.[ii]
Addition of the emotional quotient by including enactment of the garbhasamvada, will provide add-on
effect by impacting the positive thoughts among the pregnant woman.
Physical Workup - Classical
Dance form like- Bharatanatyam, Kuchipudi, Etc depend on group of hand and leg
movements called “Adavuâ€[iii].
These Adavu are based on the Semi –sitting Posture called Aramandi. Aremandi, also known as Ardhamandala[iv], is
a fundamental posture in Indian classical dance forms, especially in
Bharatanatyam and Odissi. The term "Ardhamandi" is derived from the
combination of two Sanskrit words: "Ardha," meaning half, and
"Mandi," meaning legs and knee joint. Together, Ardhamandi refers to
a semi-seated or half-squatting stance that is characteristic of the
traditional Indian dance styles.
Details of the Aramandi Posture-
Posture- Semi-squatting position with the knees bent
and the weight evenly distributed on both legs. The stance resembles the shape
of a partially opened lotus flower.
Body Alignment- The back is kept straight, and the
chest is lifted. The head is held in a neutral position with the eyes focused
on a specific point.
Symbolism- This
posture symbolizes a sense of rootedness, stability, and connection to the
earth. It is considered a strong and foundational stance, providing the dancer
with a solid base from which to execute intricate footwork, body movements, and
expressions.
Emotional
Workup- Garbhasamvada is a part of Gabhasamskar
protocol where, the mother is made to imagined to have conversation between Garbha
and Herself. In this protocol the process of imagining is made in the form of
enactment by the pregnant woman. Thus the woman feels that she is physically
doing the enactment of what she does in her imagination. This will enhance the Matrutva
bhava among the mothers and thus help in impacting positive outcome in
pregnancy.
Previous Research works:
1. Effect
of aerobic dance on cardiorespiratory fitness in pregnant women: A randomised
controlled trial Halvorsen, Silje et al.[v]
2. Aerobic
Exercise and Submaximal Functional Capacity in Overweight Pregnant Women-A
Randomized Trial- Santos et al. [vi]
3. Effect
of Garbh Sanskar (Yoga) on Maternal and Perinatal Outcome, Chaudhary A. et allz[vii]
4. The
Effect of Selected Aspect of Gabhasamskara on Stress, Coping Strategies
and Wellbeing of Antenatal Mothers, Jyotsna Deshpande et all[viii]
5. Clinical
evaluation of effect of music with creative visualization on foetal growth and
maternal physiology with special reference to E.C.G Vaishnav mauli, Usha V.N.K.[ix]
RESEARCH
QUESTION:
Is there any change in the efficacy of the Integrated
Gabhasamskara Protocol with and Without Adavu practice when compared
with Only WHO recommended guideline on maternal and foetal outcome in the 20-32
weeks of gestation?
Hypothesis-
Gabhasamskara Protocol Study:
Null Hypothesis (H0):
There is no difference in the
efficacy of the Integrated Gabhasamskara Protocol with Adavu practice and
the Gabhasamskara Protocol without Adavu Practice when compared with only WHO
recommended guidelines on maternal and foetal outcome in 20-32 weeks of gestation.
Alternate Hypothesis (H1):
There is a difference in the
efficacy of the Integrated Gabhasamskara Protocol with Adavu Practice and
the Gabhasamskara Protocol without Adavu Practice when compared
with only WHO recommended guidelines on maternal and foetal outcome in the 20-32 weeks of
gestation.
Aim:
To
evaluate and compare the efficacy of the Gabhasamskara Protocol with Adavu
Practice and the Gabhasamskara Protocol without Adavu Practice
when compared with only WHO recommended guidelines on maternal
and foetal outcome in the 20-32 weeks of gestation.
Objectives
Primary
objectives
1.
To evaluate and
compare the efficacy of integrated garbha samskara protocol and standard
Anti-natal care on outcome indicators related to maternal and foetal outcome between
20-32 weeks of Gestational age.
2.
Analytical study of
the Gokshurasiddhayavagu and medical intervention during 20-32 weeks of
gestation.
Secondary objectives
1.
To evaluate and
compare the effectiveness in lowering the maternal complications such as pregnancy
induced hyper tension, Anaemia in pregnancy.
2.
To evaluate and
compare the effectiveness in lowering the foetal adverse outcomes like Intra
Uterine growth retardation, Oligohydramnios and Polyhydramnios etc
3.
To evaluate the
effectiveness in maintaining adequate utero placental blood flow.
4.
To evaluate the effectiveness
in maintaining quality of life of pregnant women
5.
To compare the
dietary intake and nutritional status between pregnant women consuming Gokshurasiddha
Yavagu and those not consuming it within the study period.
[i] Bánkyné Perjés, B., Mátrai, G., Nagy, B., Erdei, D.,
Makai, A., Prémusz, V., Kovács, K. A., & Bódis, J. (2022). Prenatal dance
activity enhances foetal and postnatal cognitive and motor development. Physiology
International, 109(4), 486-500. https://doi.org/10.1556/2060.2022.00121
[ii] ACOG Committee Opinion. Exercise
during pregnancy and the post-partum period. Number 267, January 2002. American
College of Obstetricians and Gynecologists.IntJ Gynaecol Obstet 2002;77:79–81
[iii] Subbulakshmi, S. (2023). Geometrical Motifs in
Bharatanatyam. Humanities, 11(2), 50-53.
[iv] Jyothi, S., & Sujaya, B. (2018). Assessment of muscle
strength in female Bharatanatyam dancers. Retrieved from. International
Journal of Physiology, Nutrition and Physical Education, 3,
621-625.
[v] Effect of aerobic dance on cardiorespiratory fitness
in pregnant women: A randomised controlled trial Halvorsen, Silje et al. Physiotherapy, Volume 99, Issue 1, 42 - 48
doi:10.1016/j.physio. 2011.11.002.
[vi] Santos, I. A., Stein, R., Fuchs, S. C., Duncan, B. B.,
Ribeiro, J. P., Kroeff, L. R., ... & Schmidt, M. I. (2005). Aerobic
exercise and submaximal functional capacity in overweight pregnant women: a
randomized trial. Obstetrics & Gynecology, 106(2),
243-249.
[viii] deshpande,
Jyotsna Rajendra, Study to assess the effect of selected aspects of Gabhasamskara
on stress coping strategies and well being of antenatal mothers of Pune city,
International Journal of Science and Research (IJSR) ISSN (Online): 2319-7064
Index Copernicus Value (2013): 6.14 (2013): http://localhost:8080/xmlui/handle/123456789/1746
[ix] Vaishnav Mauli1 , Usha V.N.K,
Clinical evaluation of effect of music with creative visualization on foetal
growth and maternal physiology with special reference to E.C.G, International
Ayurvedic Medical Journal, (ISSN: 2320 5091) (August, 2017) 5(8), Available from,
http://www.iamj.in/posts/2017/images/upload/2836_2842.pdf
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