跳至主要内容
临床试验/CTRI/2024/10/075831
CTRI/2024/10/075831尚未招募不适用

A randomised control trial to assess add- on effect of nurse – led intervention programs of structured education and relaxation techniques in QOL of Psoriasis patients managed through Ayurveda at a tertiary level Ayurveda hospital in New Delhi

All India Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
1)PASI score -Symptomatic Relief in signs and symptoms(itching ,scaling ,discoloration,discharge) of Psoriasis.

研究概览

简要总结

Psoriasis is a chronic skin condition characterized by thick, raised red patches that are often covered with flaking, silvery scales. Psoriasis  can have substantial physical , psychological and social impact on patient’s life. Psoriasis has been shown to affect health-related Quality of Life to an extent similar to the effects of other chronic diseases such as depression, myocardial infarction, hypertension, cancer etc**.** The modern treatment options not only provide temporary relief but also have serious side effects. Thus, the chronic and recurring nature of the disease hampers the Quality of Life to a great extent. Information from Quality of Life surveys suggest that 78% of psoriatic indicate the negative impact on their life quality.

It is necessary to elaborate and implement a program of health education for every patient with psoriasis in order to equip them with the knowledge essential to    enable them to undertake self-care and achieve long-lasting remission of the disease. Health education is an important aspect of psoriatic treatment.

Also it has long been acknowledged that the clients affected with psoriasis may benefit greatly from psychotherapeutic interventions. It is possible that stress management through relaxation may result in improvement in these patients. Stress may worsen psoriasis severity and may even lengthen the time to disease clearance.

Significance of this research

Assessing the add- on effect of structured education and relaxation techniques  in QOL of  Psoriasis patients managed through Ayurveda will help to  develop a nursing care protocol based on selected education programs  and relaxation techniques for management of Psoriasis patients which can be followed , so that their quality of life can be improved . This nursing care protocol can be utilized as a guideline for nursing management of patients with Psoriasis in Ayurveda system.

METHODOLOGY

Research Approach: RCT

Design:     Prospective two arm clinical study (Pretest – Posttest)

Sample size – 50 for each group

INCLUSION CRITERIA

a. Age - 25 -55 yrs

b. PASI > 10

c. Chronicity – 2 Years and more

EXCLUSION CRITERIA:

a.     Chronicity of less than 2 years

b.     Patients with Severe Systemic disorders

c.     Patients with Psoriatic  Arthritis

d.     Patients unfit for relaxation techniques

e.     Patients unwilling to do OM chanting

Intervention – Structured education program, Nursing intervention****and selected relaxation techniques

  • Randomization will be used for both experimental and control group.
  • **Experimental group –**After baseline assessment of patient,  structured education, and relaxation techniqueswill be taught and Nursing intervention based on structured education  will be given.   Nursing intervention checklist, care taker checklist  , material  of structured education  and relaxation techniques will be prepared and validation will  be  done by following standard methods before  starting the data collection.

 Â¢  Structured  education  will be given on the first or second day of admission  on the following topics. Repeat session will be taken if necessary or on patient demand  :

ü  Hygiene

ü  Skin care

ü   Prevention of infection

ü  Nutrition & Diet (Pathya & Apathya)

ü  Sleep

ü  Rest & exercise

ü  Productivity of life

ü  Pain management

¢  Nurse -led intervention for Management of Psoriasis

1.     Specific nursing interventions bases on structured education  & maintaining the checklist

2.     Dietary management

3.     Practice of relaxation techniques

4.     Follow up of home care through a close family member (care taker )

  Â¢  Relaxation techniques will include selected yoga techniques which will  be taught  for fourteen days for 15-20 minutes daily at yoga hall of AIIA from second day of admission. The  techniques will be:

§  Prayer...OM chanting (30 sec)

§  Sukshma vyayam (warm up) (5min)

§  Asana-Tadasana (1min)

§  Suryanamaskar (4 min)

§  Sukhasana , Paschimottansana, Savasana (3 min : 1 min each)

§  Pranayama-Nadi Shodhana, Bhramari. (6 min : 3 min each)

§  OM chanting (30 sec)

Investigator had  undergone  short term yoga therapy course (one-month certificate course) and will also seek guidance and help from department of Swastavritta & Yoga of AIIA.

The practice of relaxation techniques will be suspended if any such condition occurs during the course of Ayurveda treatment and will restart as per instruction from the treating consultant.

  • Control group – Routine Ayurveda management  will be given to these group.

Data will be collected in following manner :

—  Assessment period

1.

Baseline assessment

1st / 2nd day of IP admission

|2.

First assessment after structured education , Nursing intervention and relaxation techniques  (F1)

14th / 15th  day during hospitalization period

|3.

Second assessment after structured education and relaxation techniques (F2)

After 15 days of F1

|4.

Third assessment after structured education and relaxation techniques (F3)

After 30 days of F2

 Follow up of home care (After discharge) :

a.     Will assign one family member (care taker )  for care of the patient  & treatment compliance  after discharge . Consent will be taken from the family member  (care taker ).

b.     Checklist based on nursing intervention checklist will be given to family member (care taker ) for monitoring the patient at home.

c.     Family member  (care taker ) will maintain a diary  record of different activities and collect pictures of the patient daily activities and will share with the investigator

d.     Researcher Will maintain the contact with the patient and family member (care taker ) over telephone

Primary outcome

Symptomatic Relief in signs and symptoms of Psoriasis

Reduction in Psoriasis Area and Severity Index (PASI) Score.

Improvement in DLQI quality of life

Secondary outcome

Development of Nursing care protocol and guideline based on Structured  education and relaxation techniques**. (Nursing intervention)**

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
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Male & Female patients with more than two years chronicity and PASI score more than 10.

排除标准

  • Chronicity of less than 2 years Patients with Severe Systemic disorders Patients with Psoriatic Arthritis Patients unfit for relaxation techniques Patients unwilling to do OM chanting.

结局指标

主要结局

1)PASI score -Symptomatic Relief in signs and symptoms(itching ,scaling ,discoloration,discharge) of Psoriasis.

时间窗: Before treatment 0 day,15th,30th and 60th day

2)Improvement in DLQI quality of life

时间窗: Before treatment 0 day,15th,30th and 60th day

次要结局

  • Reduction in Psoriasis Area and Severity Index (PASI) Score.(Before treatment 0 day and after treatment 60th day)

研究者

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

Sindhu Rajesh

College of Nursing Amity University

研究点 (1)

Loading locations...

相似试验