To evaluate the effectiveness of diaphragmatic breathing exercises and progressive relaxation techniques in patients having preeclampsia.
Design
The design of this study is Randomized, parallel Controlled Trial. Randomization is done by lottery method. In this method, the researcher gives each participant of the trial a number. Researchers draw numbers from the box randomly to allocate participants in two groups
Settings and conduct
This study is conducted at Arif Memorial Hospital. In this trial participants are blinded through concealment to avoid biasness.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Systolic BP ≥135 mmHg or diastolic BP ≥85 mmHg
Preeclampsia female diagnosed by a physician
Age group 25-40
Exclusion criteria:
Chronic hypertension
Contraction or leakage of fluid during the study
Bleeding , heart disease, and renal diseases
Intervention groups
All the subjects of the sample will be allocated to two groups randomly.
Group A: Diaphragmatic breathing exercise , progressive relaxation technique and routine hypertensive medication
Group B: only receive routine hypertensive medication
Main outcome variables
Arterial blood pressure, Oxygen saturation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220626055280N2
Registration date:2023-01-21, 1401/11/01
Registration timing:registered_while_recruiting
Last update:2023-01-21, 1401/11/01
Update count:0
Registration date
2023-01-21, 1401/11/01
Registrant information
Name
Nazeer Ahmad
Name of organization / entity
Rashid Latif medical college
Country
Pakistan
Phone
+92 333 8054247
Email address
nazeer.ahmad@rlmc.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-19, 1401/10/29
Expected recruitment end date
2023-05-19, 1402/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of diaphragmatic breathing exercise and progressive relaxation technique in patient having preeclampsia.
Public title
Effect of diaphragmatic breathing exercise and progressive relaxation technique in patient having preeclampsia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Systolic BP ≥135 mmHg or diastolic BP ≥85 mmHg
Preeclampsia female diagnosed by physician
Exclusion criteria:
Chronic hypertension
Contraction or leakage of fluid during study
Bleeding ,heart disease and renal diseases
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated into two groups i.e.; Group A and Group B, by lottery method. Lottery method is a type of simple random sampling. In this method, each participant of the trial is assigned a unique number. In the next step these numbers are written on separate cards which are physically similar in shape, size, color etc. 30 cards were used. Then they are placed in a basket and thoroughly mixed. In the last step the slips are taken out randomly without looking at them and are placed into two sets randomly. Total of 26 cards were taken out, 13 participants in each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The blinding is achieved by concealment in which the treatment allocation for each patient is not revealed to the patient. This is done to avoid biasness.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board of Rashid Latif Medical College
Street address
35-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Approval date
2022-10-05, 1401/07/13
Ethics committee reference number
IRB/2022/053
Health conditions studied
1
Description of health condition studied
Pre-eclampsia
ICD-10 code
O14.00
ICD-10 code description
Mild to moderate pre-eclampsia, unspecified trimester
Primary outcomes
1
Description
Blood Pressure
Timepoint
Pre and Post 1 Month
Method of measurement
Manual sphygmomanometer was used to evaluate blood pressure
2
Description
Oxygen Saturation
Timepoint
Pre and Post 1 Month
Method of measurement
Pulse oximeter is used to measure oxygen saturation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will receive Diaphragmatic breathing exercise , progressive relaxation technique and routine hypertensive medication. Progressive muscular relaxation technique will be performed by Conscious removal of tension from the muscles: Contractions start from the hands to the sole muscles (each muscle group was contracted for 5–7 sand then relaxed for 30–40 s). Then make Fist and tighten your hand, then relax. Now Push the elbow down on the chair and then relax arm. Raise your eyebrows and wrinkle your forehead, then relax your forehead. Furthermore, Close your eyes tightly, then open slowly. For Muscles of the central part of the face, Cross your eyes and pull the nose upwards. Moreover, to relax the lower part of face, jaw and neck, Tie your teeth and tighten the corners of your mouth, then relax. For Shoulders, Raise your shoulders as if you want to touch the ears, then relax. Chest and abdomen muscles can be relaxed by taking a deep breath and hold it, then exhale (Abdominal muscle contraction was avoided due to avoiding preterm labor contractions in this study). For Legs muscles, Pull your toes down, away from your body, and then relax. Furthermore, for anterior thighs, Contract the muscles above and below the thigh and then relax. For Hamstrings muscle Push heels down into floor ,tighten hamstrings muscles and relax. Lastly For Calves, Points toes toward head and relax. Curl toes toward the bottom of feet and relax. At the Completion, Check the whole body for the remaining tension, If you experience tension or pressure in certain muscles, repeat the muscle contraction and relaxation for that group of muscles. Diaphragmatic Breathing will be done by Getting comfortable. You can lie on your back in bed or plinth with a pillow under your head and knees. Or you can sit in a chair with your shoulders, head, and neck supported against the back of the chair and Breathe in through your nose. Let your belly fill with air. Then Breathe out through your nose. Now, Place one hand on your belly and the other hand on your chest. As you breathe in, feel your belly rise. As you breathe out, feel your belly lower. The hand on your belly should move more than the one that's on your chest. Take three more full, deep breaths. Breathe fully into your belly as it rises and falls with your breath. The technique will be applied for 3 days a week, and a single session will be 20 minutes. 5 minutes for diaphragmatic breathing exercise and 15 minutes for progressive relaxation technique
Category
Treatment - Other
2
Description
Control group: The control group only receive routine hypertensive medication
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arif Memorial Hospital
Full name of responsible person
Kalsoom
Street address
35-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Phone
+92 318 8384198
Email
kalsoomkanwal51@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Nazeer Ahmad
Street address
35-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Phone
+92 333 8054247
Email
nazeer.ahmad@rlmc.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rashid Latif Medical College
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Kalsoom
Position
Physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 318 8384198
Email
kalsoomkanwal51@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Nazeer Ahmad
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
35-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 333 8054247
Email
nazeer.ahmad@rlmc.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Nazeer Ahmad
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
35-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 333 8054247
Email
nazeer.ahmad@rlmc.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available