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临床试验/CTRI/2024/11/076821
CTRI/2024/11/076821尚未招募2 期

Integrated Garbhasamskara Protocol with and without Adavu practice on Maternal and Foetal outcome- A Randomized Control Trial

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年11月29日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Maternal outcome- 1. Prevention of PIH, Anaemia

研究概览

简要总结

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 “Adavu”[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 20-32weeks 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 International109(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. Humanities11(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 Education3, 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 & Gynecology106(2), 243-249.

[vii] Anjali Chaudhary Chaudhary, Umesh Varma, Aditya Varma, Deepali Chaudhary, Devishri Bhatnagar, Niti Agrawal, Jahnvi Shanker, Effect of Garbh Sanskar (Yoga) on Maternal and Perinatal Outcome. Int J Med Res Rev. 2022;10(1):17-23. Available From https://ijmrr.medresearch.in/index.php/ijmrr/article/view/1365

[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

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • 1.Women, with age group between 21 to 40 years with single viable pregnancy confirmed by USG.
  • 2.Singleton pregnancy, with gestational age from 20-32nd weeks (Primigravida and multigravida) 3.Participants having H/O Pregnancy induced hypertension, Oligo hydramnios, Poly hydramnios and Intra Uterine growth retardation in previous pregnancy.

排除标准

  • 1.Previous history of any major systemic illness such as H/o chronic respiratory disease, H/o cardiac disease, Tubercular infections and uncontrolled diabetes mellitus.
  • 2.Pregnant women with uterine anomalies such as bicornuate uterus, cervical incompetence and multiple gestation.
  • 3.Pregnancy associated with any gynaecological complications such as cervical fibroid, large ovarian cyst, and genital prolapse.
  • 4.Low lying Placenta, Placenta Previa – Grade 1,2, 3,
  • 5.Pregnant with H/O Cervical incompetence.
  • 6.Participants with H/O bleeding PV (Per Vagina) in the current pregnancy.
  • 7.K/C/O Knee joint, hip joint and Ankle joint affected participants.

结局指标

主要结局

Maternal outcome- 1. Prevention of PIH, Anaemia

时间窗: 20TH WEEK TO 32 WEEK OF GESTATION (12WEEKS)

2.Comparison of values with standard care –Umbilical, Uterine artery

时间窗: 20TH WEEK TO 32 WEEK OF GESTATION (12WEEKS)

3. Comparison of AFI values with Standard Care

时间窗: 20TH WEEK TO 32 WEEK OF GESTATION (12WEEKS)

Fetal outcome-

时间窗: 20TH WEEK TO 32 WEEK OF GESTATION (12WEEKS)

1. Changes in Foetal growth: HC, AC, BPD, FL

时间窗: 20TH WEEK TO 32 WEEK OF GESTATION (12WEEKS)

2. Changes in Doppler velocimetry- PI, RI Index

时间窗: 20TH WEEK TO 32 WEEK OF GESTATION (12WEEKS)

次要结局

  • Maternal Outcome:(1.Prevention and changes in Minor ailments)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr. Nidhi Devidas Chickramane

National Institute of Ayurveda

研究点 (1)

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