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临床试验/NCT05869981
NCT05869981尚未招募不适用

Association Between Periodontal Status and Mental Health in Postpartum Women: A Cross Sectional Study

Postgraduate Institute of Dental Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2023年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
128
试验地点
1
主要终点
Correlation of periodontal status and mental health status

研究概览

简要总结

Background- In developing countries like India, seeking mental health care is still a taboo, and a lot of stigma is attached to consulting a psychiatric specialist or a counselor. This problem magnifies during postpartum period characterized by depressive symptoms in mothers indicating persistent low mood and feeling of worthlessness with easy fatigability, poor appetite, and sleep deprivation which leads to lack of interest in daily activities including oral health care.

Rationale- Many studies have evaluated the periodontal status during pregnancy and its consequences but only few studies have been conducted evaluating the periodontal status during the postpartum period. None of the study has evaluated the association of Mental health and periodontitis during postpartum period.

Objectives-To assess the Association between Periodontal status and Mental health in Postpartum women Methods- Periodontal Status and Mental health status (by Mental Health Inventory) will be assessed in Women during postpartum period (6-8 weeks- 6 months after delivery).

Expected outcomes- Study of periodontal status during postpartum period may contribute in elucidating this interrelationship and helps to design better prevention strategies for women's mental health.

详细描述

AIM To assess the Association between Periodontal status and Mental health in Postpartum women OBJECTIVES Primary objectives :- Evaluation of periodontal status and mental health status in postpartum women.

Secondary objectives:- Assessment of corelation of sociodemographic characteristics with periodontal parameters and mental health status in the postpartum women.

MATERIAL AND METHODS STUDY DESIGN AND SETTINGS The present cross sectional study will be conducted in the department of Periodontology, PGIDS, Rohtak This will be an observational cross sectional study.

STUDY PERIOD : 4 MONTHS

SAMPLE SIZE- A sample size of total 128 participants was calculated by using formula of sample size calculation with an moderate effect size 0.5 alpha =0.05 and power=0.80. n, required for each group is given by:- n=(Zα/2+Zβ)2 α2/ 2 The cross sectional study will include Women (Age 25-35 years) screened 6-8 weeks- 6 months after delivery.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
25 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Correlation of periodontal status and mental health status

时间窗: 4 months

Periodontal parameters:- Plaque index, Gingival index, Probing pocket depth, Clinical attachment loss \& Bleeding on probing Mental health Status: A standard 38 items Mental Health Inventory (MHI-38) developed by Veit and Ware(1983) . MHI-38 items divided into six subscales, consisting of two general scales, * Psychological distress with 24 items (anxiety - 9 items, depression - 4 items, loss of behavioural/ emotional control - 9 items) and * Psychological well-being with 14 items (overall positive affect - 10 items, emotional ties - 2 items and satisfaction with life - 1 item). Higher scores on three subscales indicate positive states of mental health and higher scores on the other three subscales indicate negative states of mental health.

次要结局

  • Correlation of sociodemographic characteristics with periodontal status(Plaque index, Gingival index, Probing pocket depth, Clinical attachment loss, Bleeding on probing) and mental health status(Mental Health Inventory [MHI] )(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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