Comparison of Gua Sha Technique and Therapeutic Breast Massage Technique for Treatment of Breast Engorgement in Postnatal Women A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Six point breast engorgement scale
研究概览
简要总结
This study aims to compare the effectiveness of the Gua Sha technique and the Therapeutic Breast massage technique for the treatment of breast engorgement in postnatal women. Procedure of the study is approval from the Institutional Ethical Committee, which is obtained before commencing the study. CTRI registration will be done. Participants will be selected based on inclusion and exclusion criteria. All the participants will be informed about the study, and a written consent form will be taken from them. 60 postnatal women will be randomly allocated to either intervention group, and outcomes including pain and severity of breast engorgement will be assessed. Data will be analyzed to determine comparative effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Postnatal lactating women 2) Able to give written informed consent 3) Having signs and symptoms of breast engorgement (pain, swelling, firmness of the breast tissue) 4) Scoring 2 and above on the point breast engorgement scale.
排除标准
- •Pre-existing breast conditions such as mastitis, abscesses, or a history of previous such conditions 2) Participants with a history of breast surgery (e.g., implants, reduction, or lumpectomy) 3) Women with severe postnatal complications (e.g., postpartum hemorrhage, preeclampsia) 4) Women on medications that affect lactation (e.g., lactation suppressants, hormone therapy) 5) Participants with open wounds, skin infections, or any dermatological conditions on the breasts 6) Non-cooperative patients 7) Medical conditions affecting circulation or requiring specific treatments 8) Women who are unable to give consent or participate due to language barriers or cognitive issues.
- •Participants who decline to provide informed consent or are unwilling to comply with the study requirements.
结局指标
主要结局
Six point breast engorgement scale
时间窗: Pre intervention baseline, Post intervention immediately, 24 hours, post intervention fourth day
次要结局
- Numerical Pain Rating Scale(Pre intervention baseline, Post intervention immediately, 24 hours, post intervention fourth day)
研究者
Dr Ritika Awate
Terna Physiotherapy College