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临床试验/NCT07333625
NCT07333625已完成不适用

Integrating Spiritual Care Into Type 2 Diabetes Management: Effects on Psychological Resilience, Distress, and Glycemic Control

Universitas Noor Huda Mustofa1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Psychological Resilience

研究概览

简要总结

This study aims to evaluate the effects of integrating spiritual care into the management of patients with type 2 diabetes mellitus. The study examines whether a structured spiritual care program can improve psychological resilience, reduce psychological distress, and help control blood glucose levels in adults with type 2 diabetes. Participants receive standard diabetes care, with one group also receiving spiritual care interventions delivered by trained health professionals. The findings of this study are expected to support a more holistic approach to diabetes management that addresses both physical and psychological well-being.

详细描述

This study is a randomized controlled clinical trial designed to evaluate the impact of integrating spiritual care into standard management for adults with type 2 diabetes mellitus. Psychological distress and reduced resilience are common among patients with chronic illnesses such as diabetes and may negatively influence glycemic control. Integrating spiritual care into routine diabetes management may help address these psychosocial challenges and improve overall patient well-being.

Eligible participants with type 2 diabetes mellitus were randomly assigned to one of two groups. The experimental group received standard diabetes care combined with a structured spiritual care program, while the control group received standard diabetes care alone. The spiritual care intervention was delivered by trained health professionals and included supportive spiritual counseling, reflective practices, and discussions tailored to patients' beliefs and coping needs.

Primary outcomes of the study included changes in psychological resilience, psychological distress, and glycemic control as measured by blood glucose levels. Secondary outcomes included additional psychological and clinical indicators relevant to diabetes management. Outcome assessments were conducted at baseline and after completion of the intervention period.

The study was conducted in a hospital setting in Indonesia and followed ethical principles for research involving human participants, with approval obtained from an institutional ethics committee. The findings are expected to provide evidence to support holistic and patient-centered approaches to diabetes care that integrate spiritual and psychological dimensions alongside standard medical treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who can read and communicate well;
  • Clinically diagnosed with type II di-abetes; and
  • Patients over the age of 40
  • Willing to participate and provide written informed consent

排除标准

  • Diagnosed with severe psychiatric disorders
  • Having cognitive impairment that interferes with participation

研究组 & 干预措施

Standard Diabetes Care

Active Comparator

Participants received standard diabetes care without additional spiritual care intervention.

干预措施: Standard Diabetes Care (Behavioral)

Spiritual Care Plus Standard Care

Experimental

Participants received standard diabetes care combined with a structured spiritual care program.

干预措施: Spiritual Care Program (Behavioral)

Spiritual Care Plus Standard Care

Experimental

Participants received standard diabetes care combined with a structured spiritual care program.

干预措施: Standard Diabetes Care (Behavioral)

结局指标

主要结局

Psychological Resilience

时间窗: Baseline and post-intervention (4 weeks)

Psychological resilience measured using a validated resilience questionnaire, with higher scores indicating greater resilience.

Psychological Distress

时间窗: Baseline and post-intervention (4 weeks)

Psychological distress assessed using a standardized psychological distress scale, with higher scores indicating greater distress.

Blood Glucose Level

时间窗: Baseline and post-intervention (4 Weeks)

Fasting blood glucose level measured in milligrams per deciliter (mg/dL).

次要结局

未报告次要终点

研究者

发起方
Universitas Noor Huda Mustofa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Faisal Amir

Universitas Noor Huda Mustofa

Universitas Noor Huda Mustofa

研究点 (1)

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