| CTRI Number |
CTRI/2025/08/093457 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To find the Effect of Diaphragmatic breathing and Bensons Relaxation Technique on Anxiety and Fatigue during Pregnancy |
|
Scientific Title of Study
|
Effect of Diaphragmatic breathing and Bensons Relaxation Technique on Anxiety and Fatigue during Pregnancy: 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 |
Shruti kukreja |
| Designation |
Student |
| Affiliation |
Dr APJ Abdul Kalam college of Physiotherapy |
| Address |
Community Department Of Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7330444447 |
| Fax |
|
| Email |
shrutikukreja03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepali Hande |
| Designation |
Professor and Head of Department |
| Affiliation |
deepali.hande@pmtpims.org |
| Address |
Community Department Of Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences (DU) Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8275034001 |
| Fax |
|
| Email |
deepali.hande@pmtpims.org |
|
Details of Contact Person
Public Query
|
| Name |
Shruti kukreja |
| Designation |
Student |
| Affiliation |
Dr APJ Abdul Kalam college of Physiotherapy |
| Address |
Community Department Of Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7330444447 |
| Fax |
|
| Email |
shrutikukreja03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Community Physiotherapy Department Dr Abdul Kalam college of Physiotherapy PIMS(DU) Loni Ahmadnagar 413736 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shruti kukreja |
Dr APJ Abdul Kalam College of Physiotherapy PIMS(DU) |
OPD No-404 Fourth floor Community Physiotherapy Department
Ahmadnagar
MAHARASHTRA |
7330444447
shrutikukreja03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional Group |
Group A
Diaphragmatic Breathing. Participant will be in supine position.
Instruction for participants(Given in local Language)
Bend your knees while lying on your back on a level surface, such as your bed. If its more comfortable, you can support yourself with a pillow beneath your head and legs.
Touch your tummy, right below your rib cage, with one hand and your upper chest with the other.
Take a calm, deep breath through your nose and direct it toward your lower abdomen. While the hand on your tummy should rise, the one on your chest should stay motionless.
As you release the breath through pursed lips, contract your abdominal muscles and allow them to drop inward. The hand on your stomach ought to return to its starting position.
Duration:
Five inspirations and expirations per set
2 sets per day
5 days per week
For 4 weeks
|
| Comparator Agent |
Experimental Group |
Group B Diaphragmatic breathing Bensons relaxation technique
Diaphragmatic breathing:
Same as group A
Bensons relaxation technique
Instructions for participants
Take a seat comfortably and silently.
Shut your eyes.
O Start at your feet and work your way up to your face, deeply relaxing every muscle. Keep them at ease. Calm down and your thoughts will stop.
O Use your nose to breathe. Pay attention to your breathing. Say the word "one" to yourself in a quiet voice as you exhale. Say "one", for instance, and then exhale, then repeat "one." Breathe naturally and effortlessly.
Continue for 10 minute You may open your eyes to check the time, but do not use an alarm. When you finish, sit quietly for several minutes, at first with your eyes closed and later with your eyes opened. Do not stand up for a few minutes.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant women in their second or third trimester.
2.Participants experiencing mild to moderate anxiety or fatigue.
3.Individuals willing to participate and practice the techniques regularly.
4.Those without any contraindications to relaxation or breathing exercises.
|
|
| ExclusionCriteria |
| Details |
1.Participants with severe medical conditions or complications during pregnancy.
2.Individuals with a history of psychiatric disorders requiring medication.
3.Those already practicing similar relaxation or breathing techniques.
4.Participants unwilling to comply with the study protocol.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Multidimensional Assessment of Fatigue Scale
Becks Anxiety Inventory (BAI)
|
week0-week4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Pittsburgh Sleep Quality Index (PSQI)
|
week0-week4 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Pregnancy often brings physical, emotional, and psychological stress. Anxiety and fatigue are common due to hormonal, physiological, and psychological changes. Pharmacological treatments pose risks; hence, non-pharmacological methods like relaxation techniques are explored. Diaphragmatic breathing promotes relaxation by improving oxygenation and lowering respiratory rate. Benson’s relaxation technique is a simple, evidence-based stress reduction method using mindful breathing and passive awareness. Methodology: Participants: Pregnant women (2nd or 3rd trimester) with mild to moderate anxiety/fatigue. Sample Size: 60 women (30 per group).Group A: Diaphragmatic breathing only. Group B: Diaphragmatic breathing + Benson’s relaxation technique .Duration: 4 weeks. Outcome Measures :Multidimensional Assessment of Fatigue (MAF). Beck Anxiety Inventory (BAI). Pittsburgh Sleep Quality Index (PSQI). Intervention: Pre Intervention Baseline Assessment (MAF+BAI+PSQI) Group 1 •Diaphragmatic
Breathing. Participant will be in
supine position.
•Instruction
for participants:
(Given in local Language)
oBend
your knees while lying on your back on a level surface, such as your bed. If
it’s more comfortable, you can support yourself with a pillow beneath your head
and legs.
oTouch
your tummy, right below your rib cage, with one hand and your upper chest with
the other.
oTake
a calm, deep breath through your nose and direct it toward your lower abdomen.
While the hand on your tummy should rise, the one on your chest should stay
motionless.
oAs
you release the breath through pursed lips, contract your abdominal muscles and
allow them to drop inward. The hand on your stomach ought to return to its
starting position.
• Duration:
o Five inspirations and expirations per set
o 2 sets per day
o 5 days per week
o For 4 weeks Group 2 Diaphragmatic
breathing + Bensons relaxation technique
• Diaphragmatic breathing:
o Same as group A
• Bensons relaxation technique
Instructions for participants
O
Take a seat comfortably and silently.
O
Shut your eyes.
O
Start at your feet and work your way up to your face, deeply relaxing every
muscle. Keep them at ease. [Calm down—and your thoughts will stop.]
O
Use your nose to breathe. Pay attention
to your breathing. Say the word
"one"* to yourself in a quiet voice as you exhale. Say "one"*, for instance, and then
exhale, then repeat "one."
Breathe naturally and effortlessly.
O
Continue for 10 minute You may open your eyes to check the time, but do not use
an alarm. When you finish, sit quietly for several minutes, at first with your
eyes closed and later with your eyes opened. Do not stand up for a few minutes. Do
not worry about whether you are successful in achieving a deep level of
relaxation. Maintain a passive attitude and permit relaxation to occur at its
own pace. When distracting thoughts occur, try to ignore them by not dwelling
upon them and return to repeating "one."*
O
With practice, the response should come with little effort. Practice the
technique once or twice daily, but not within two hours after any meal, since
the digestive processes seem to interfere with the elicitation of the
Relaxation Response.
*Choose
any soothing, mellifluous sounding word, preferably with no meaning or
association, to avoid stimulation of unnecessary thoughts.
• Duration:
o 10 minutes
o 2 times per day
o 5 days per week
o For 4 weeks
Post Intervention Baseline Assessment (MAF+BAI+PSQI) |