Combined Effect of Pomegranate Juice and Cold Hip Bath on Primary Dysmenorrhea A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- changes in pain intensity checked through visual analogue scale
研究概览
简要总结
Title****Combined Effect of Pomegranate Juice and Cold Hip Bath on Primary Dysmenorrhea A Pilot Study
This study is a Randomized parallel group pilot study in single center trial to check the combined effect of pomegranate juice and cold hip bath on primary dysmenorrhic women primary outcome measures change in pain intensity through Visual analogue scale and Secondary outcome measures change in quality of life using Euro QOL 5 dimension 5 level questionnaire
PURPOSE OF THIS STUDY
Quantitative analysis shows prostaglandins levels are 13 times higher in dysmenorrhic women than non dysmenorrhic women
Pomegranate contains ellagic acid shows to inhibit prostaglandins and According to J H Kellogg a short application of cold treatment produces tonic effect
We want to identify natural feasible and cost effective treatment to reduce pain intensity and improve quality of life in primary dysmenorrhic women
AIM AND OBJECTIVES OF RESEARCH
Aim
To evaluate the efficacy of pomegranate juice along with cold hip bath on primary dysmenorrhea
Objective
To check the efficacy cold hip bath on reducing pain intensity in primary dysmenorrhea
To check the efficacy of cold hip bath on quality of life in primary dysmenorrhea
To check the efficacy of pomegranate juice as an add on therapy along with cold hip bath on reducing pain intensity in primary dysmenorrhea
To check the efficacy of pomegranate juice as an add on therapy along with cold hip bath on quality of life in primary dysmenorrhea
Hypothesis
Null hypothesis is Pomegranate juice along with cold hip bath will not reduce the intensity of pain and will not improve quality of life in primary dysmenorrhea
Hypothesis Pomegranate juice helps to reduce the intensity of pain and improves quality of life in primary dysmenorrhea as an add on therapy along with cold hip bath due to its inhibitory effects on prostaglandin synthesis
METHODS
Participants
Female college students of the age group 18 to 25 with primary dysmenorrhea will be include in study subjects will be requested to fill the online consent form which also includes details about height weight medical conditions and menstrual cycle
Based on inclusion & exclusion criteria subjects will be recruited
Study design Randomized control pre and post pilot study design
Diagnostic criteria Menstrual symptom questionnaire MSQ is a 24 item self report measure which assesses menstrual pain and symptoms
The score on each item ranges from 1 never to 5 always with a higher composite score indicating more symptoms
Inclusion criteria
Age between 18 to 25 years female college students will be included
On MSQ Scale mild to moderate scoring females will be included
Exclusion criteria subjects will be excluded if
They have irregular menstrual cycle
Secondary dysmenorrhea
Any Co morbidities
Intervention
Group 1Would be givencold hip bath 55 to 65 degree Fahrenheit for 8minutes for 1 week prior to menstruation for consecutive 2 menstrual cycles
Group 2Pomegranate juice 200ml will be given on empty stomach 1 week prior to menstruation followed by 3 days during menstruation along with cold hip bath 55 to 65 degree Fahrenheit for 8 minutes will be given 1 week prior to menstruation for consecutive 2 menstrual cycles
1monthfollow up on subsequent cycle will also be conducted
Assessment
Assessment tools used in the study are Visual analogue scale VAS and Quality of life by EuroQol 5 dimensions 5 levels VAS was used to asses pain and QOL is used to assess the changes in quality of life before and after intervention
DATA ANALYSIS
Date will be collected before the onset of intervention after the completion of the study of 2 months and follow up after 1 month Tabulation of the data will be done in Excel2021 Descriptive and interferential statistics will be implied and data assessment will be done through JASP 0 16 4 software Value of p less than 0 05 will be considered as significant
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 25.00 Year(s)(—)
- 性别
- Female
入选标准
- •Age between 18 to 25 years female college students will be included based On MSQ Scale mild to moderate scoring females will be included.
排除标准
- •subjects will be excluded if They have irregular menstrual cycle Secondary dysmenorrhea or Any Comorbidities.
结局指标
主要结局
changes in pain intensity checked through visual analogue scale
时间窗: 3 time points | prior to the study | immediately after the study | one month after follow up
次要结局
- changes in quality of life checked through Euro QOL 5 dimension 5 level questionnaire(3 time points)
研究者
Dr Swathi B S
Swami Vivekananda Yoga Anusandhana Samsthana
