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
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.
¢ 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 )
¢ 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
Sindhu Rajesh
College of Nursing Amity University
