A Comparative Analysis of Stretching Exercise and Pregnancy Exercise on Sleep Quality in Pregnancy: A Quasi Experiment
Phase: NA
Conditions: Sleep Deprivation, Sleep Wake Disorders, Pregnancy, Anxiety Disorders, Stretching Exercises, Relaxation Therapy
Sponsor: Health Polytechnic of Palangka Raya

 
  
 
CLINICAL STUDY PROTOCOL 
The Effect of Pregnancy 
Exercise on Sleep Quality in 
Third Trimester Pregnant 
Women in Palangka Raya City, 
Central Kalimantan 
 
Erina Eka Hatini | Vissia Didin Ardiyani | Addina Yusti Islamadina 
Date: 1 August 2025 
Protocol ID: 121/II/KE.PE/2024 
 

 
1. GENERAL INFORMATION 
● Principal Investigator: Erina Eka Hatini 
● Affiliation: Midwifery Department, Health Polytechnic of Palangka Raya – Indonesia 
Ministry of Health 
● Co-Investigators: * Addina Yusti Islamadina (Midwifery Dept, Polkesraya) 
○ Vissia Didin Ardiyani (Nursing Dept, Polkesraya) 
● Study Site: [Insert specific clinic/hospital names or "Community Health Centers in 
Palangka Raya"] 
● Sponsor/Funder: [Insert Funder if applicable, e.g., Self-funded or Ministry of Health] 
 
2. BACKGROUND AND RATIONALE 
2.1 Problem Statement 
Sleep disturbances are highly prevalent among pregnant women, particularly in the third 
trimester. Poor sleep quality can lead to adverse maternal and fetal outcomes, including 
increased risk of preeclampsia, prolonged labor, and depressive symptoms. While 
pharmacological interventions are often avoided during pregnancy due to safety concerns, 
non-pharmacological interventions such as physical activity are recommended. 
 
2.2 Rationale 
Physical activity is known to improve sleep quality in the general population. However, 
comparative data regarding specific types of exercise—specifically Traditional Pregnancy 
Exercise (Senam Hamil) versus Stretching Exercises—is limited. Understanding which modality 
is more effective for improving sleep quality (assessed via PSQI) will help healthcare providers 
prescribe the most appropriate activity for third-trimester mothers. 
 
2.3 Research Hypothesis 
1. There is a significant difference in sleep quality scores between pregnant women 
performing traditional pregnancy exercises and those performing stretching exercises. 
2. Both exercise modalities will result in improved sleep quality scores compared to 
baseline. 
 
3. STUDY OBJECTIVES 
3.1 Primary Objective 
To compare the effectiveness of Traditional Pregnancy Exercise versus Stretching Exercise 
on sleep quality scores in third-trimester pregnant women. 

 
3.2 Secondary Objectives 
● To assess the change in anxiety levels (HARS scores) associated with both exercise 
interventions. 
● To evaluate physiological responses (blood pressure/diastolic measures) pre- and post-
intervention. 
 
4. STUDY DESIGN 
4.1 Study Type 
● Type: Interventional (Clinical Trial) 
● Design: Quasi-Experimental (Non-randomized trial) 
● Allocation: Non-randomized Parallel Assignment (Two Arms) 
● Masking: Open Label (Participants and instructors know the intervention; Outcome 
assessors should ideally be blinded if possible). 
 
4.2 Study Timeline 
● Estimated Start Date: 4th August 2025 
● Estimated Completion Date: 4th October 2025 
● Intervention Duration: 3 weeks per participant, 45-60 minutes per session. 
 
5. STUDY POPULATION 
5.1 Sample Size 
Total sample size: N = 60 
● Intervention Group: n = 30 
● Control (Comparator) Group: n = 30 
𝑛= 2 [
(𝑍1−𝛼
2 + 𝑍1−𝛽) 𝑆
𝑋1 −𝑋2
]
2
 
𝑛= 2 [
(1,96 + 0,84)2,9910925540121
6,84 −10,10
]
2
 
𝑛= 2 [(2,8)2,9910925540121
−3,26
]
2
 

𝑛= 2 [8,3750591512338
−3,26
]
2
 
𝑛= 2[−2,569036549458]2 
𝑛= [−5,138073098916]2 
𝑛= [26,399795169806]  
n= 26,399795169806 adding 10%.  
Therefore, a minimum of 30 respondents per group is required  
 
S value is calculated in the following: 
 
𝑆= √𝑆1
2(𝑛1 −1) + 𝑆2
2(𝑛2 −1)
𝑛1 + 𝑛2 −2
 
𝑆= √2,862 (39 −1) + 3,122 (38 −1)
39 + 38 −2
 
𝑆= √2,862 (39 −1) + 3,122 (38 −1)
39 + 38 −2
 
𝑆= √8,1796(38) + 9,7344(37)
75
 
𝑆= √310,8248 + 360,1728
75
 
𝑆= √670,9976
75
 
𝑆= √670,9976
75
 
𝑆= √8,9466346666 
𝑆= 2,9910925540121 
 
 

Notes : 
n   
: Sample size 
Z  
: Z-score 
𝑍1−𝛼/2 
: 1.96 at the 95% confidence interval 
𝑍1−𝛽 
: Statistical power at 0.84  
S  
: Standar deviasi gabungan 
X1 – X2 
: The minimum significant mean difference observed in prior research (6,84)  
                   (6,84 – 10,10 = -3,26) (Blanquea,dkk. 2018) 
S  
: Weighted average of standard deviations from two groups (2,99)  
S1  
: Standard deviation in group 1 (2,86) (Blanquea,dkk. 2018) 
n1  
: Sampel size in group 1 (39) 
       S2  
: Standard deviation in group 2 (3,12) (Blanquea,dkk. 2018) 
n2  
: Sampel size in group 2 (38) 
 
5.2 Inclusion Criteria 
1. Pregnant women in the third trimester (Gestational age 28–40 weeks). 
2. Singleton pregnancy. 
3. Willing to participate and sign informed consent. 
4. Able to perform moderate physical activity. 
5. Based in the study catchment area (Palangka Raya). 
5.3 Exclusion Criteria 
1. History of high-risk pregnancy (e.g., placenta previa, history of preterm labor, 
preeclampsia). 
2. Contraindications to exercise as defined by ACOG guidelines (e.g., ruptured membranes, 
incompetent cervix). 
3. Taking sleep medication. 
4. Severe musculoskeletal disorders preventing exercise. 
 
6. INTERVENTIONS 
6.1 Group A: Traditional Pregnancy Exercise (Intervention Group) 
● Description: A structured exercise program specifically designed for pregnant women 
("Senam Hamil"). 
● Components: Includes breathing exercises, muscle strengthening (pelvic floor, 

abdominal), and relaxation techniques specifically standardized for pregnancy 
preparation. 
● Frequency: [Insert Frequency, e.g., 1 session per week supervised + home practice]. 
● Duration: [Insert Time, e.g., 45 minutes per session]. 
6.2 Group B: Stretching Exercise (Active Control Group) 
● Description: A regimen focusing on static stretching and flexibility. 
● Components: Gentle stretching of major muscle groups (calves, hamstrings, lower back, 
neck) to relieve tension and improve circulation without the aerobic or intensive 
strengthening components of the traditional class. 
● Frequency: Matched to Group A. 
● Duration: Matched to Group A. 
6.3 Adherence Monitoring 
Participants will utilize a logbook to record exercise sessions. Attendance at supervised 
sessions will be recorded by the instructor. 
 
7. OUTCOME MEASURES 
7.1 Primary Outcome 
● Measure: Sleep Quality. 
● Instrument: Pittsburgh Sleep Quality Index (PSQI) - Indonesian validated version. 
● Time Frame: Baseline (Pre-test) and Post-intervention (Post-test, after [X] weeks). 
● Metric: Total PSQI score (Range 0-21; lower scores indicate better sleep quality). 
7.2 Secondary Outcomes 
● Anxiety Levels: Measured using the Hamilton Anxiety Rating Scale (HARS). 
● Hemodynamics: Systolic and Diastolic Blood Pressure. 
7.3 Confounding Variables 
● Age, Parity, BMI, Gestational Age. 
 
 
8. STATISTICAL ANALYSIS PLAN 
8.1 Data Management 
Data is collected via paper questionnaires and entered into a digital database (SPSS). Data 
cleaning is performed to check for outliers and missing values. 
 
8.2 Statistical Methods 

● Descriptive Statistics: Means/Standard Deviations for continuous variables; 
Frequencies/Percentages for categorical variables. 
● Baseline Comparability: Independent t-tests or Chi-square tests to ensure groups are 
balanced at baseline (specifically checking HARS and Diastolic BP as noted in preliminary 
analysis). 
● Outcome Analysis: A Linear Mixed Model is used to analyze the difference between 
groups while adjusting for baseline scores and confounding variables (e.g., Age, Parity). 
● Significance Level: p-value < 0.05. 
 
9. ETHICS AND SAFETY 
9.1 Ethical Approval 
This protocol will be submitted to the Ethical Review Board of [Insert Name, e.g., Health 
Polytechnic of Palangka Raya]. 
 
9.2 Informed Consent 
Written informed consent will be obtained from all participants prior to enrollment. 
Participants will be informed of the benefits and potential risks of physical activity during 
pregnancy. 
 
9.3 Safety Monitoring 
Participants will be monitored for any adverse events (dizziness, contractions, pain). The 
intervention will be stopped immediately if any warning signs of pregnancy complications 
occur. 

Figure S1. Traditional Pregnancy Exercise 
No 
Movement 
Position 
1 
Warm-up 
 
 
Position: Standing, 
feet shoulder-width 
apart. 
Instructions: 
• Begin with slow 
breathing: inhale 
through the nose, 
exhale through the 
mouth. 
• Gently roll 
shoulders forward 
and backward 5–
10 times. 
• Rotate the neck 
slowly in both 
directions. 
• March lightly in 
place for 1–2 
minutes to warm 
the muscles. 
Purpose: Prepare the 
body, increase 
circulation, and 
reduce injury risk. 
 
2 
Deep 
Breathing 
and Chest 
Opening 
 
 
 
 
 
 
Position: Standing 
or sitting upright 
Instructions: 
• Place both hands 
on the sides of 
the ribcage. 
• Inhale deeply, 
expanding the 
chest and ribs 
outward. 
• Exhale slowly 
while relaxing 
the shoulders. 
• 
Repeat 8–10 
times. Purpose: 
Improve 
oxygenation, reduce 
tension, and 
promote relaxation. 
 

3 
Pelvic Tilts 
 
Position: Standing 
with back against a 
wall or on hands and 
knees Instructions: 
• Gently tilt the 
pelvis forward and 
backward, 
tightening the 
abdominal 
muscles. 
• Avoid arching the 
lower back 
excessively. 
• Perform 10–12 
repetitions. 
Purpose: Reduce 
lower-back 
discomfort and 
strengthen core 
stability. 
 
4 
Cat–Cow 
Stretch 
 
Position:  
Hands and knees 
(“tabletop” position) 
Instructions: 
• Inhale while 
dropping the 
belly and lifting 
the head (cow). 
• Exhale while 
rounding the 
back and tucking 
the chin (cat). 
• Move slowly 
with the breath 
for 10 cycles. 
Purpose: Relieve 
back tension and 
improve spinal 
flexibility. 
 
5 
Hip Circles 
 
Position:  
Standing, hands on 
hips  
Instructions: 
• Gently rotate the 
hips in a circular 
motion 
clockwise for 10 
repetitions. 
• Repeat 
counterclockwise 
for another 10 
repetitions. 

Purpose: Loosen 
pelvic muscles and 
prepare for 
childbirth. 
 
6 
Side 
Stretch 
 
Position: Standing 
or sitting 
Instructions: 
• Raise the right 
arm overhead and 
gently bend to the 
left. 
• Hold for 10–15 
seconds while 
breathing 
normally. 
• Switch sides and 
repeat.  
Purpose: Stretch the 
torso, reduce ribcage 
tightness, and 
improve breathing 
comfort. 
 
7 
Squat with 
Support 
 
Position:  
Standing, holding a 
chair or wall for 
balance 
Instructions: 
• Slowly lower into 
a comfortable 
squat, keeping feet 
wide and knees 
aligned. 
• Hold for 5–10 
seconds, then rise 
slowly. 
• Repeat 8–10 
times.  
Purpose: Strengthen 
legs and pelvic floor, 
improve hip 
flexibility. 
 
8 
Butterfly 
Stretch 
 
Position:  
Sitting on the floor 
Instructions: 
• Bring the soles of 
the feet together 
and let the knees 
fall outward. 
• Hold the ankles 
and gently press 

the knees toward 
the floor. 
• Maintain the 
stretch for 20–30 
seconds.  
Purpose: Open the 
hips and improve 
pelvic flexibility. 
 
9 
Pelvic 
Floor 
(Kegel) 
Exercise 
 
Position:  
Sitting or lying down 
Instructions: 
• Contract the 
pelvic floor 
muscles as if 
stopping urine 
flow. 
• Hold for 5 
seconds, then 
relax for 5 
seconds. 
• Repeat 10–15 
times.  
Purpose: Strengthen 
pelvic muscles to 
support pregnancy 
and childbirth. 
 
10 
Ankle and 
Leg Stretch 
 
Position:  
Sitting with legs 
extended  
Instructions: 
• Point and flex the 
feet 10 times. 
• Rotate ankles 
clockwise and 
counterclockwise 
10 times each. 
• Gently stretch the 
calves by pulling 
toes toward the 
body.  
Purpose: Improve 
circulation and 
reduce leg cramps or 
swelling. 
 
11 
Cool-Down 
and 
Relaxation 
 
Position:  
Sitting or lying on 
the left side 
Instructions: 
• Take slow, deep 
breaths for 1–2 
minutes. 

• Relax the 
shoulders, jaw, 
and hands. 
• Visualize 
calmness and 
release tension 
throughout the 
body.  
Purpose: Lower 
heart rate, promote 
relaxation, and 
complete the session 
safely. 
 
 

Figure S2. Stretching Exercise 
No 
Movement 
Position 
1 
Iskium 
Tibialis 
 
 
Lying on the 
surface, the 
therapist 
elevates the 
lower limb in 
extension and 
ankle 
dorsiflexion (3 
x 20 sec repeats, 
bilaterally and 
alternately). 
 
2 
Gluteus 
Maksimal 
 
 
Lying on the 
surface, with 
one lower limb 
in flexion and 
external rotation 
of the hip and 
knee, and the 
ankle resting on 
the contralateral 
thigh, the 
therapist 
manually 
increases hip 
flexion towards 
the opposite 
shoulder (3 x 
20-second 
repetitions, 
bilateral and 
alternating). 

3 
Piriformis 
 
 
Lying on the 
surface with one 
lower limb in 
flexion and 
external rotation 
of the hip and 
knee, and the 
ankle resting on 
the contralateral 
thigh, the 
therapist 
manually 
conducts hip 
adduction 
towards the 
opposite lower 
limb (3 x 20-
second 
repetitions, 
bilaterally and 
alternating). 
4 
Paravertebral 
 
 
Sitting on the 
edge of a 
surface with 
abducted lower 
limbs and feet 
resting on the 
floor. Perform 
trunk flexion for 
freight and 
sideways while 
supported up on 
a Swiss grid ball 
(3 x 15 sec reps, 
bilaterally and 
alternating). 

5 
Kuadratus 
Lumborum 
 
 
The therapist 
manually 
stretches the 
lumbar square 
in lateral 
decubitus, 
performing two 
20-second 
repetitions on 
each side. 
6 
Latissimus 
Dorsi 
 
 
In a supine 
position with 
the upper 
extremities in 
180º flexion, the 
therapist 
manually 
lateralises the 
pregnant 
woman's upper 
trunk to 
contralateral 
elongation (2 x 
20 second 
repetitions, 
bilaterally). 

7 
Skalane 
 
 
The therapist 
conducts 
cervical rotation 
and flexion in a 
supine position 
to lengthen the 
contralateral 
scalene (2 x 20 
second 
repetitions, 
bilaterally). 
 
8 
Trapesium 
 
 
The therapist 
conducts lateral 
tilt and cervical 
flexion to the 
contralateral 
trapezius in a 
supine position, 
with two 20-
second 
repetitions 
performed 
bilaterally. 
 
Source: (Fontana Carvalho et al., 2020) 
 
 
Fontana Carvalho, A. P., Dufresne, S. S., Rogerio de Oliveira, M., Couto Furlanetto, K., Dubois, M., 
Dallaire, M., Ngomo, S., & da Silva, R. A. (2020). Effects of lumbar stabilization and muscular 
stretching on pain, disabilities, postural control and muscle activation in pregnant woman 
with low back pain. Eur J Phys Rehabil Med, 56(3), 297-306. 
https://doi.org/https://doi.org/10.23736/S1973-9087.20.06086-4  
 

Informed Consent Form for Participation in a 
Research Study 
Study Title: Effects of Traditional Pregnancy Exercise on Sleep Quality Among Third-Trimester 
Pregnant Women 
Version Date: July 12, 2025 
Introduction and Purpose of the Study 
You are being invited to take part in a research study that aims to understand how different types of 
exercise may affect sleep quality during the third trimester of pregnancy. Many pregnant women 
experience difficulty sleeping due to physical discomfort, hormonal changes, and increased anxiety as 
they approach childbirth. Poor sleep can affect daily functioning, emotional well-being, and overall 
pregnancy health. Although exercise is often recommended to support comfort and relaxation during 
pregnancy, there is limited research comparing specific types of exercise programs and how they 
influence sleep.. 
Your participation is entirely voluntary. Before you decide, please read this form carefully. It explains 
why we are doing this study, what will happen if you take part, what the possible benefits and risks are, 
and your rights as a participant. Please ask the study team any questions you have. 
 
Why you are chosen 
You are being invited because you are: 
• 
A pregnant woman in your third trimester 
• 
Receiving antenatal care at this clinic 
• 
Able to participate in light to moderate exercise 
 
What will happen if I participate? 
If you agree to participate, you will be part of a study involving 60 pregnant women.  
You will then be assigned to one of two study groups  
1. Group 1: Traditional Pregnancy Exercise 
• 
Attend two supervised exercise sessions per week for three weeks 
• 
Each session lasts 45–60 minutes 
• 
Complete questionnaires on sleep quality and anxiety before and after the program 
• 
You may also receive printed or video materials for home practice 
 
2. Group 2: Stretching Exercise (Control Group) 
o 
Attend two supervised exercise sessions per week for three weeks 
o 
Each session lasts 45–60 minutes 
o 
Complete questionnaires on sleep quality and anxiety before and after the program 
o 
You may also receive printed or video materials for home practice 
 

How long will I be in the study? 
Your total participation in this study will last about three weeks. During this time, you will attend 
supervised exercise sessions twice a week and complete questionnaires at the beginning and end of the 
program. 
Risks and Discomforts 
The exercises are low-to-moderate intensity and generally safe for pregnant women. However, you 
may experience: 
• 
Mild muscle soreness 
• 
Temporary fatigue 
• 
Discomfort during certain movements 
If you feel pain, dizziness, shortness of breath, or any unusual symptoms, you should stop 
immediately and inform the instructor or midwife. 
There are no known serious risks associated with these exercise programs when performed correctly. 
 
Benefits of Participation 
Participating in this study may offer several personal benefits. The exercise sessions are designed 
specifically for women in their third trimester and may help you feel more comfortable as your 
pregnancy progresses. Many women find that gentle movement, stretching, and breathing exercises can 
reduce muscle tension, improve posture, and promote relaxation. These effects may help you feel more 
at ease during daily activities and may support better physical comfort overall. 
Another possible benefit is improved sleep. Many pregnant women experience difficulty sleeping due 
to discomfort, anxiety, or changes in their body. The exercise programs used in this study are intended 
to support better sleep quality by helping your body relax and by reducing some of the physical 
discomforts that can interfere with rest. While we cannot guarantee that your sleep will improve, the 
activities included in the program have been shown to be safe and may help you feel more rested. 
In addition to any personal benefits, your participation will contribute to a better understanding of how 
different types of exercise affect sleep during late pregnancy. The information gathered from this study 
may help improve antenatal care programs and support other pregnant women in the future. 
 
Confidentiality 
Your privacy and the confidentiality of your data will be strictly protected. 
• 
All information collected during this study will be kept confidential and will be identified only 
by a unique study code, not by your name. 
• 
Any personal identifying information will be removed from your data as soon as possible. 
• 
Study data will be stored securely on password-protected computers and in locked cabinets. 
• 
The anonymized individual participant data (IPD) from this study may be shared with other 
qualified researchers in the future to further scientific discovery. This sharing will occur after 
the study's main results are published, and only under strict data use agreements that ensure 

your privacy is protected through de-identification and anonymization methods, as outlined in 
our study's data sharing plan. No information that could identify you will ever be shared. 
• 
 
Voluntary Participation and Right to Withdraw 
Your decision to participate in this study is entirely voluntary. You are free to refuse to participate or to 
withdraw your consent and discontinue participation at any time, for any reason, without penalty or loss 
of benefits to which you are otherwise entitled. If you choose to withdraw, your decision will not affect 
your standard antenatal care. 
 
Costs 
There are no costs to you for participating in this study. 
 
Who to Contact for Questions or Problems 
If you have any questions about this research study, please feel free to contact the lead researcher: 
Erina Eka Hatini 
Midwifery Department, Health Polytechnic of Palangkaraya  
Phone: +62812-5456-4640 
 
If you have any questions about your rights as a research participant, or if you have concerns or 
complaints about the study, you may contact: 
Research Committee of the Health Polytechnic of Palangka Raya (Polkesraya)  
Yeni Lucin (Ethics Committee Coordinator)  
+62 812-5087-359; Email: lucinyeni@polkesraya.ac.id 
as per approval number 470/II/KE.PE/2025 
 
--------------------------------------------------------------------------------------------------------------------------- 
Statement of Consent 
I have read and understood the information provided in this consent form. I have had the opportunity to 
ask questions, and my questions have been answered to my satisfaction. I understand that my 
participation is voluntary and that I may withdraw at any time without penalty. 
By signing below, I freely and voluntarily agree to participate in this research study. 
Participant's Name: _________________________ 
Participant's Signature: _________________________ 
Date: _________________________ 
Person Obtaining Consent Name: _________________________ 
Person Obtaining Consent Signature: _________________________ 
Date: _________________________