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CTRI Number  CTRI/2025/03/083683 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Complementary Acupressure and instrumentaL music (CALM)]  
Study Design  Randomized Factorial Trial 
Public Title of Study   Effectiveness of complementary therapy for postnatal issues among postnatal women admitted in a tertiary referral hospital, Sikkim 
Scientific Title of Study   Effectiveness of Complementary Acupressure and instrumentaL Music (CALM) for uterine afterpains, postpartum fatigue, sleep quality, and postnatal anxiety among postnatal women in a tertiary referral hospital, Sikkim: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arpana Basnett 
Designation  Ph.D. Scholar 
Affiliation  Manipal College of Nursing (MCON), MAHE 
Address  Manipal College of Nursing (MCON), MAHE, Manipal

Udupi
KARNATAKA
576101
India 
Phone  8373899480  
Fax    
Email  arpana.mconmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonia R B DSouza 
Designation  Professor and HoD 
Affiliation  Manipal College of Nursing (MCON), MAHE 
Address  Manipal College of Nursing (MCON), MAHE, Manipal

Udupi
KARNATAKA
576101
India 
Phone  9606035384  
Fax    
Email  sonia.r@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Arpana Basnett 
Designation  Ph.D. Scholar 
Affiliation  Manipal College of Nursing (MCON) 
Address  Manipal College of Nursing (MCON), MAHE, Manipal

Udupi
KARNATAKA
576101
India 
Phone  8373899480  
Fax    
Email  arpana.mconmpl2023@learner.manipal.edu  
 
Source of Monetary or Material Support  
Self-funded study that is planned to be conducted in STNM Hospital, Sochakgang, Gangtok, Sikkim 
 
Primary Sponsor  
Name  Arpana Basnett 
Address  Manipal College of Nursing (MCON), MAHE, Manipal 
Type of Sponsor  Other [Self-funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Arpana Basnett  Sir thutob namgyal memorial hospital Hospital  Postnatal wards of Sir Thutob Namgyal Memorial Hospital, Sochakgang, Sikkim
East
SIKKIM 		 8373899480

arpana.mconmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sir thutob namgyal memorial hospital Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Post-natal women who have undergone normal vaginal delivery 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Complementary Acupressure and instrumentaL music (CALM)   Acupressure and instrumental music will be provided as an intervention for the participants. one group will receive acupressure, another will receive instrumental music, the third group will receive both acupressure and instrumental music and the last group will be he control group. The total duration of the intervention is 6 weeks. 
Comparator Agent  Complementary Acupressure and instrumentaL music (CALM)  The intervention will be compared to the standard care protocol and also with the single intervention (Acupressure and instrumentaL music) and the combination of both. The total duration is for 6 weeks. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details 
Age more than 21 years

Post-natal women, admitted to the post-natal wards: who underwent spontaneous or assisted vaginal delivery.

Who have had a full-term fetus (at 37-40 weeks)

Who are free from life-threatening complications of puerperium- like primary or secondary PPH, convulsions, retained/morbidly adherent placenta, atony of uterus, etc.
 
 
ExclusionCriteria 
Details  Mothers with haemoglobin of less than 8gm/dl

Mothers who have had a stillbirth, intrauterine fetal death and had a fetus/newborn with life-threatening illnesses or congenital anomalies.

Mothers who are a known case of a mental health illness or under any psychiatric drugs.

who have received acupressure within 24 hours.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
• This study will help us to evaluate the effectiveness of CALM in:
• reducing the level of afterpain,
• reduce post-partum fatigue,
• increase sleep quality
• reducing the postnatal anxiety

• Based on the findings of this study it will help the staff nurse and student nurses to use this method in the practice area routinely to reduce the afterpains, increase activity tolerance, sleep quality and reduce the post-natal anxiety in hospital and community as well.
 		 the intervention outcome will be assessed at baseline and then 2 days after the intervention and finally after 6 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
This study will help us to evaluate the effectiveness of CALM in:
reducing the level of afterpain,
reduce post-partum fatigue,
increase sleep quality
reducing the postnatal anxiety

Based on the findings of this study it will help the staff nurse & student nurses to use this method in the practice area routinely to reduce the afterpains, increase activity tolerance, sleep quality & reduce the post-natal anxiety in hospital & community as well.
 		 the intervention outcome will be assessed at baseline & then 2 days after the intervention & finally after 6 weeks. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study aims to assess the effectiveness of complementary acupressure and instrumental music for postnatal issues among the postnatal women admitted to tertiary referral hospital of Sikkim. 
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